• Marketing Director
• Marketing Manager
• Senior Product Manager
• Key Account Manager - Philadelphia / New Jersey
• Key Account Manager for Carolinas & Maryland
• Key Account Manager for Northern California
• Director of RA/QA
• Senior Regulatory Affairs Specialist
• Process Engineering Director
• Director of Marketing and Product Development
• Director of IDN Sales/Development
• Vice President of Operations
• Director of Retail Marketing - DME
• Regulatory Affairs Specilist
• CEO

Marketing Manager

Our client, a leading manufacturer of Diagnostic products seeks a Marketing Manager.  This company is a division of a Global Multi-Billion Healthcare company. 

Responsibilities:

• Plans and implements worldwide business plan for each product segment in assigned portfolio including marketing and competitive assessment, definition of customer needs and opportunities, distribution channel strategies, multi-year product maps, financial operational and brand management objectives, with required tactical programs to support product strategic objectives.  Planning may be with product development or distribution channel partners. 
• Develops and executes annual WW marketing plan for product line(s) to ensure the achievement of financial. /budget expectations and project line strategies. 
• Monitors product sales, forecast performance to budget, forecast monthly requirements for manufacturing. 
• Manages marketing communication programs including advertising, direct mail, product literature, sales tools, Internet sites, CRM and eMarketing/iPad tools etc. in alignment with product line strategy.  Development of effective sales aids and training materials for use with Regional Clinical Microbiology Sales, Training Managers and International/Domestic Distributors. 
• Responsible for establishing and analyzing product pricing.  Coordinates with Finance and Cost Accounting the provisions of accurate product costs in support of regional pricing and profitability planning.
• Employs market research tools as required to identify and interpret global changing user attitudes, demands, and needs for existing company and competitive products. 
• Review product descriptions, technical specifications, product labeling and product packaging to ensure application information is appropriate for intended audiences and that information and design supports the product’s brand strategy.
• Provides marketing and/or technical support at conventions, user’s meetings, workshops and other specific marketing functions. 
• Develops and executives plans to optimize communications to sales force and customers during product constraints and technical product issues.  Coordinate in conjunction with Quality, Operations, Technical Service, and Customer Services functions.
• Drive product development programs, including portfolio life cycle management, partnership programs and new product development.  Support OEM relationships.
• Requires a BS or MSc in Molecular Biology, Microbiology, or related science/engineering, with MBA highly preferred. 
• Minimum 4 years of product and/or marketing management experience managing a broad portfolio of products.  Experience editing contracts, working with third party distributors, and supporting a sales organization required. 
• Has developed and implemented:  WW pricing and branding strategies, detailed marketing plans.
• Demonstrates effective communication and presentation skills, and can work internationally with diverse cultures, including ability to provide training for direct and distributor partners sales forces. 
• Proficient in EXCEL, Power Point.
• Strong verbal and written communications and analytical skills.
• Has a history of achieving and delivering against key objectives and timelines.
• Able to work at a fast pace with minimal supervision. 

Compensation will include an excellent base, bonus and outstanding benefits package.

Senior Product Manager

Our client, a leading Salt Lake City based Medical Device company is seeking a Senior Product Manager.

General Function:
The Product Management function within the company manages the product across its entire lifecycle. This Sr. Product Manager is responsible for product management activities to meet objectives for the product. Specifically, the Sr. Product Manager will develop and maintain marketing plans, product road maps and the supporting technology road maps. In addition, will contribute to the development of strong competitive position through identification of marketing opportunities, sustainable product/technology advantages, and a strong working relationship with distributors and the sales organization. Lastly, the Sr. Product Manager will collaborate with internal project teams to bring products to market, address quality and service related issues, and work with the product management team to resolve major customer problems.

Scope:
The Sr. PM position reports to Group Director of Marketing and Product Management and will work closely with Engineering, Sales, Clinical, Customer Advocacy, Quality Assurance, Operations and Regulatory Affairs personnel. The candidate must be highly motivated and excel in an environment where the implementation of the marketing plans, product development, and or supporting existing business hinges on their ability to work with the various internal functions.

The Sr. PM is responsible for the creation of a product and/or strategic marketing plan for their product line, including:
Target market identification (what markets, segments, problems to solve, and needs to meet)
• Articulation of a market position (source of differentiation)
• Identification of product line requirements
• Suggestions on pricing strategy – list prices, discount levels, tiers, sale vs. lease, and so on
• Support of the go-to-market strategy
• Creation of communications objectives and issues that need to be addressed in a communications plan.

Desired Skill Set:
• Project Management – successful experience in managing multiple projects simultaneously to support product development, marketing plan implementation and resolving customer issues.
• Product Development Process – ability to work with a product development team to bring products to market including the documentation required for regulatory approval, product introduction and customer satisfaction.
• Problem Solving – ability to solve customer problems through working with internal personnel.
• Market Research– qualitative and quantitative research techniques, understanding of basic research approaches, research design and a firm grasp of statistical analysis.
• Marketing Communications – message design, and the implementation of effective strategies and initiatives.
• Pricing – understanding of generic pricing strategies and tactics, including determining price sensitivity, margin and break-even sales analysis, and economic value analysis.
• Product Prowess – understanding the theory of operation, applications, and customer needs (existing and emerging)

Challenging Aspects:
• This position will include both upstream and downstream marketing responsibilities.
• Identifying approaches to continue gaining market share in existing products.
• Appreciating customer views of competitive products and capabilities.
• Understanding market dynamics in terms of what drives demand, and market share changes.
• Creating customer requirements documents using voice of the customer (VOC) research and other    market research tools.
• Development of future product road maps, which may include targeted technologies
• Actively participating as a member of new product development teams and launching new products.
• Maintaining and expanding existing product line, through product line extensions, new messaging, and repositioning.
• Keeping product lines current in all internal systems and ensuring that customers are satisfied with all services.
• Improving customer awareness level, interest, and desire that lead to a communications strategy.
• Enhancing market share and growth, or profitability thorough pricing strategy and financial modeling.
• Working with Pricing and Contracts Manager to manage the pricing process.

Experience:
The ideal candidate will have marketing and/or product management experience. Suggested experience of:
• At least 5 years of business experience in medical devices or the healthcare industry
• A minimum of 5 years of product management experience
• A minimum of 3 years of project management experience

Education:
A Bachelor’s degree in a related field is required. An MBA is highly preferred.

Benefits:
The company offers a wide range of benefits, including, comprehensive medical and dental insurance at competitive rates, life insurance, short and long term disability insurances, 401(k) plan with a company match, generous paid time off policy for work life balance, and the opportunity to work in a team environment.

Key Account Manager - Philadelphia / New Jersey

Our client, a well-known manufacturer of Bioprocessing products seeks a Key Account Manager for Philadelphia/New Jersey. 

This position offers the right candidate a key position in the sales organization and will provide opportunities for career development and growth. As the world’s largest manufacturer of single use bioprocessing related products.  The company is expanding its sales, marketing, customer support and supply chain teams.

The Key Accounts Manager is responsible for meeting and exceeding his or her assigned corporate accounts and product line territory forecasts.  This will be accomplished by aggressively pursuing new sales opportunities and by effectively establishing strong business relationships with our current and future client base. The Key Account Manager is responsible for developing and continually updating effective written key account business plans for each major account to ensure that we are expanding our market share at a double-digit growth rate. The Key Account Manager has additional responsibility for seeking out new business potentials within secondary target accounts and engaging all appropriate resources to achieve maximum results for the company.

Key Responsibilities:

• Market all products in assigned geographic territory by using exceptional selling skills to exceed pre-established territory forecasts.
• Work weekly with our channel partners to develop and close sales.
• Continually promote company’s breadth of product offerings on all sales calls to achieve maximum client solution opportunities and greater sales potentials for the company.
• Develop detailed business plans for each key account in order to achieve double-digit annualized growth.  To be reviewed quarterly with the VP of Sales.
• Participate as a team member in all assigned corporate and focus account initiatives.
• Consistently (daily), update the company CRM (Maximizer) sales funnel reports of projected bookings to assist in monthly company sales forecasting and product build plans.
• Provide commitments of expected bookings on a bi-weekly, monthly and quarterly basis and assume ownership of accuracy.
• Aggressively pursue new selling opportunities and correctly identify same on all quotation submittals.
• Control expenses against pre-established budget and submit required reports on a timely basis.

Job Requirements:

• Bachelor’s Degree with emphasis in the Life Sciences, strong understanding of pharmaceutical and biotech marketplace with a concentration on downstream bioprocessing, liquid handling, filtration, and automation is required. A minimum of 5-10 years of highly successful filtration sales experience required.  An MBA is highly preferred.
• Must have an exceptional understanding of our markets and be knowledgeable of bioprocessing, filtration and cell culture laboratory and production product applications.
• Strong knowledge of assigned account base and 3-5 years direct experience as a corporate account manager or national account manager.
• Must have ongoing relationships with Directors, Senior Management and Strategic Assets within his accounts.
• Exceptional analytical capability and problem solving skills.
• Ability to work in a team atmosphere and influence others to achieve results.
• Self-motivated with strong bias for action.
• Excellent interpersonal and persuasive communications abilities
• Substantiated capability to effectively negotiate and close business.
• Evidence of professional presentation skills.
• Outstanding follow up and organizational skills
• Willingness to travel to accomplish assigned goals. Expected to be available for travel 20-40%.
• Specialized knowledge of capital procurement processes within the biopharmaceutical market.

Key Account Manager for Carolinas and Maryland

Our client, a well-known manufacturer of Bioprocessing products seeks a Key Account Manager for Carolinas and Maryland.   

This position offers the right candidate a key position in the sales organization and will provide opportunities for career development and growth. As the world’s largest manufacturer of single use bioprocessing related products.  The company is expanding its sales, marketing, customer support and supply chain teams.

The Key Accounts Manager is responsible for meeting and exceeding his or her assigned corporate accounts and product line territory forecasts.  This will be accomplished by aggressively pursuing new sales opportunities and by effectively establishing strong business relationships with our current and future client base. The Key Account Manager is responsible for developing and continually updating effective written key account business plans for each major account to ensure that we are expanding our market share at a double-digit growth rate. The Key Account Manager has additional responsibility for seeking out new business potentials within secondary target accounts and engaging all appropriate resources to achieve maximum results for the company.

Key Responsibilities:

• Market all products in assigned geographic territory by using exceptional selling skills to exceed pre-established territory forecasts.
• Work weekly with our channel partners to develop and close sales.
• Continually promote company’s breadth of product offerings on all sales calls to achieve maximum client solution opportunities and greater sales potentials for the company.
• Develop detailed business plans for each key account in order to achieve double-digit annualized growth.  To be reviewed quarterly with the VP of Sales.
• Participate as a team member in all assigned corporate and focus account initiatives.
• Consistently (daily), update the company CRM (Maximizer) sales funnel reports of projected bookings to assist in monthly company sales forecasting and product build plans.
• Provide commitments of expected bookings on a bi-weekly, monthly and quarterly basis and assume ownership of accuracy.
• Aggressively pursue new selling opportunities and correctly identify same on all quotation submittals.
• Control expenses against pre-established budget and submit required reports on a timely basis.

Job Requirements:

• Bachelor’s Degree with emphasis in the Life Sciences, strong understanding of pharmaceutical and biotech marketplace with a concentration on downstream bioprocessing, liquid handling, filtration, and automation is required. A minimum of 5-10 years of highly successful filtration sales experience required.  An MBA is highly preferred.
• Must have an exceptional understanding of our markets and be knowledgeable of bioprocessing, filtration and cell culture laboratory and production product applications.
• Strong knowledge of assigned account base and 3-5 years direct experience as a corporate account manager or national account manager.
• Must have ongoing relationships with Directors, Senior Management and Strategic Assets within his accounts.
• Exceptional analytical capability and problem solving skills.
• Ability to work in a team atmosphere and influence others to achieve results.
• Self-motivated with strong bias for action.
• Excellent interpersonal and persuasive communications abilities
• Substantiated capability to effectively negotiate and close business.
• Evidence of professional presentation skills.
• Outstanding follow up and organizational skills
• Willingness to travel to accomplish assigned goals. Expected to be available for travel 20-40%.
• Specialized knowledge of capital procurement processes within the biopharmaceutical market.

Key Account Manager - Northern California

Our client, a well-known manufacturer of Bioprocessing products seeks a Key Account Manager for Northern California.

This position offers the right candidate a key position in the sales organization and will provide opportunities for career development and growth. As the world’s largest manufacturer of single use bioprocessing related products.  The company is expanding its sales, marketing, customer support and supply chain teams.

The Key Accounts Manager is responsible for meeting and exceeding his or her assigned corporate accounts and product line territory forecasts.  This will be accomplished by aggressively pursuing new sales opportunities and by effectively establishing strong business relationships with our current and future client base. The Key Account Manager is responsible for developing and continually updating effective written key account business plans for each major account to ensure that we are expanding our market share at a double-digit growth rate. The Key Account Manager has additional responsibility for seeking out new business potentials within secondary target accounts and engaging all appropriate resources to achieve maximum results for the company.

Key Responsibilities:

• Market all products in assigned geographic territory by using exceptional selling skills to exceed pre-established territory forecasts.
• Work weekly with our channel partners to develop and close sales.
• Continually promote company’s breadth of product offerings on all sales calls to achieve maximum client solution opportunities and greater sales potentials for the company.
• Develop detailed business plans for each key account in order to achieve double-digit annualized growth.  To be reviewed quarterly with the VP of Sales.
• Participate as a team member in all assigned corporate and focus account initiatives.
• Consistently (daily), update the company CRM (Maximizer) sales funnel reports of projected bookings to assist in monthly company sales forecasting and product build plans.
• Provide commitments of expected bookings on a bi-weekly, monthly and quarterly basis and assume ownership of accuracy.
• Aggressively pursue new selling opportunities and correctly identify same on all quotation submittals.
• Control expenses against pre-established budget and submit required reports on a timely basis.

Job Requirements:

• Bachelor’s Degree with emphasis in the Life Sciences, strong understanding of pharmaceutical and biotech marketplace with a concentration on downstream bioprocessing, liquid handling, filtration, and automation is required. A minimum of 5-10 years of highly successful filtration sales experience required.  An MBA is highly preferred.
• Must have an exceptional understanding of our markets and be knowledgeable of bioprocessing, filtration and cell culture laboratory and production product applications.
• Strong knowledge of assigned account base and 3-5 years direct experience as a corporate account manager or national account manager.
• Must have ongoing relationships with Directors, Senior Management and Strategic Assets within his accounts.
• Exceptional analytical capability and problem solving skills.
• Ability to work in a team atmosphere and influence others to achieve results.
• Self-motivated with strong bias for action.
• Excellent interpersonal and persuasive communications abilities
• Substantiated capability to effectively negotiate and close business.
• Evidence of professional presentation skills.
• Outstanding follow up and organizational skills
• Willingness to travel to accomplish assigned goals. Expected to be available for travel 20-40%.
• Specialized knowledge of capital procurement processes within the biopharmaceutical market.

Director of RA/QA

Our client, a leading Boston based Class III Medical Device company, is currently seeking a Director of RA/QA.  This individual will lead the development, implementation and maintenance of the Cardiac Care divisions quality and regulatory compliance management system across the global business. This individual will ensure that Cardiac is compliant with Good Manufacturing Practices, regulatory agencies and corporate expectations. 

Job Responsibilities

• Direct management of Quality Engineering, Quality Control, Quality System, Complaint and Regulatory staff.

• Ensure that the Quality System is compliant, effective and efficient and will easily withstand audits by regulatory agencies and third parties. 

• Is responsible to develop, coordinate prepare, compile, submit, and maintain domestic FDA 510(k) submissions and international EU Technical Files and Canadian submissions.

• Effectively functions as the company representative and the Senior Quality and Regulatory contact and strategist with the FDA, international regulatory agencies and Notified Bodies.

• Serves as the FDA correspondent and FDA audit liaison as well as the company’s Management Representative for ISO 13485.

• Monitors the US and international regulatory environments, and provides executive management with assessments of the impact of new and changing regulations on the company’s business in respect to compliance to most current regulatory requirement (FDA, MDD, CMDCAS).

• Translates Quality and Regulatory Requirements into terms understood by the business and process owners resulting in efficient solutions to worldwide regulatory compliance.

• Assists in the preparations of policies and procedures to comply with regulatory requirements.

• Coordinates the review and approval of product labeling and advertising.  Review marketing promotional materials and provides leadership / guidance in the development of compliant sales training, advertising and detail literature. 

• Maintains and manages customer complaint systems including compliant investigations and trending and the personnel that support the team.

• Established and oversees company’s internal auditing and external supplier management audit programs and reports findings to executive management.  Develops, implements and maintains QSR and ISO 13485 compliant design change processes.

• Provides input to proposals and projects plans to ensure the product development process meets FDA clearances approvals including appropriate Verification and Validation activities.  Provides complaint Quality and Regulatory strategies to support, encourage, and deliver innovative ideas from proof of concept through end of product life.

• Develops and implements QSR/GMP training programs for direct reports and other functional groups to assure awareness of all requirements and maintain compliance with all current regulations. 

• Provides leadership in departmental human resources management in collaboration with the department managers (recruitment, performance management, training/career development, interdepartmental communication)

Education/Experience Requirements

• Bachelor’s degree in Engineering, Sciences or other related field.  Masters preferred.
• Must have working knowledge of FDS, QSR, European MDD, Canadian CMDCAS and ISO 13485 quality system regulations.
• Knowledge of medical device development process in the US as well as international regulations/laws. 
• 10+ years of experience in medical device industry – prefer Class III and Cardiac if possible.
• Experience with medical device regulatory submissions for FDA 510(k) submissions and European technical files. 

Specialized Skills

• Solid knowledge of US and International regulations & standards.
• Strong leadership and people management skills.
• Excellent written/verbal communication.
• Ability to lead and contribute to discussions with executive management on strategy and policy.
• Ability to understand, interpret and explain complex device development details and regulations to non-experts.
• Maintain and communicate high ethical standards and respect.
• Demonstrated ability to develop QA professionals to both lead and manage a functional QA department.
• Ability to multi-task in a fast-paced, high pressure environment.

Compensation

• Is commensurate with industry standards.
• Excellent benefit package

Senior Regulatory Affairs Specialist

Our client, a well known Boston area based manufacturer of Medical Devices seeks a Senior Regulatory Affairs Specialist.  This is a mid-level leadership position which integrates regulatory knowledge throughout the product lifecycle with aspects of effective project management and strategy. The position supports the Regulatory Affairs function by leading the coordination and preparation of global regulatory premarket submissions.

Company Overview

Diversified global company with a significant presence in medical technology.  They design, manufacturer and distribute medical devices for critical care and surgical applications serving customers in more than 140 countries.  The company is focused on medical device technology that enables healthcare providers to improve outcomes, reduce infections and improve patient and provider safety. 

Position Overview

Experience mid-level leadership position which integrates regulatory knowledge throughout the product lifecycle with aspects of effective project management and strategy.  The position supports the Regulatory Affairs function by leading the coordination and preparation of global regulatory premarket submissions. 

Job Responsibilities

• Lead product family focused team of Regulatory Associate(s) and or Specialist(s) utilizing strong technical regulatory skills in developing strategies for complex projects and issues. 
• Assist in the mentoring and development of Regulatory Affairs Associates and Specialists as required. 
• Participate on multidisciplinary teams and communicate regulatory requirements effectively.
• Provide regulatory input to product lifecycle planning.
• Conduct appropriate research to develop strong regulatory strategies for new products.
• Determine issues which may create regulatory obstacles and investigate solutions.
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
• Oversee the organization and preparation of high quality regulatory submissions.
• Oversee preparation and submission of applicable regulatory reports as required.
• Participate in risk management assessments.
• Evaluate regulatory impact of proposed design and manufacturing changes to commercially distributed medical devices.
• Review and approve product labeling, advertising, and promotional information.
• Assist in regulatory due diligence process.
• Maintain electronic and paper regulatory files as required by departmental procedure.
• Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders.

Education/Experience Requirements

• Bachelor’s degree in scientific discipline such as a life sciences or engineering.  Equivalent experience may be acceptable in lieu of a degree.
• Minimum 5 years Medical Device Regulatory Affairs experience with demonstrated leadership skills, RAC certification expected.  Class Three Medical Device.
• Ability to apply business and Regulatory Affairs ethical standards: analytical and critical thinking skills.
• Strong verbal and writing communication skills; demonstrated leadership skills.
• Ability to manage multiple projects and meet deadlines.
• Proficient in MS Word, Excel, Power Point, and Outlook required. 

Compensation

• Depending on experience will be in the $100k area plus bonus and excellent benefit package. 

Process Engineering Director

Our client, a well known pharmaceutical company seeks a Process Engineering Director.  This person will report to the Vice President of Operations and manage the Packaging and Processing, Technology and Innovation within multiple facilities.

Job Responsibilities:

• Develop Innovative Packaging Opportunities that help to differentiate services in the market.
• Develop Solutions to product Safety issues in the market.
• Develop “In Line” Printing Solutions while maintaining label print quality.
• Develop Quality integrated processing systems through the use of technologies like:

• Scanning/Vision systems
• Weight Verification systems
• Robotics
• Fluid Pumping
• Labeling Systems
• Packaging Systems
• Material Movement Systems

• Manage Environmental, Health and Safety standards and programs for all equipment.
• Develop/Manage process improvement projects and tracking systems.
• Perform other duties as needed and assigned.

Qualifications:

• Bachelor’s Degree in Engineering or related field.
• Minimum of seven years with a major pharmaceutical, food or consumer products company in the full responsibility of facility management.
• Strong project management and problem solving skills, and expedience in working with contractors.
• AutoCAD experience and Microsoft Office skills required.
• Ability to travel approximately 25-30%

Director of Marketing and Product Development

Our client, a well known manufacturer of Coatings and Performance Materials sold to hospitals, pharmaceutical manufacturing industrial market places seeks a Director of Marketing and Product Development. 

As a key member of the company’s leadership team, assists in determining the direction and key strategies for the business and managing the business plan.  Identifies and develops new business opportunities and assists in bringing them into commercial reality.  Shares responsibility for product line profitability and meets established milestones.

This person will lead a team of product managers, product development/formulation chemists and a lead generation group.

Duties and Responsibilities:

• Establishes pricing policy and communicates it to the organization.
• Develops, communicates and drives the implementation of product aspirations, strategy, and tactics through operations, R&D, and senior management, e.g. operational efficiency, and timely/accurate reporting of sales and profitability, maximizing profit.
• Develops and maintains annual product budgets and resources. Achieves annual budget targets.
• Coordinate activities of a cross-functional business team as required by product line, including R&D, marketing, operations, logistics, and sales.
• Coordinate short-term production and logistics optimization against sales forecasts.
• Manage and maintain product information flow interfaces between groups both internal/external.
• Resolve problems to ensure customer satisfaction through coordinated efforts with sales and marketing.
• Identify new business opportunities, evaluate and develop as appropriate.
• Develop business/product specific strategies necessary to support development and commercialization of new products/technologies.
• Creates annual MARCOM (Marketing Communication Plan) to include trade shows, advertising and closed loop generation programs.
• Supervises marketing personnel.

Minimum Education, Experience, and/or Skills Required: 

• B.S. degree in Business, Marketing, or related degree required.
• Must have five plus years of experience in marketing with progressive management responsibilities.
• Must possess excellent verbal, written and presentation skills.
• Must be capable of playing a strategic and tactical role in serving as a catalyst and leader within the company.
• Must have the ability to utilize a variety of advanced software applications (Microsoft Office, Excel, Work, PowerPoint).
• Strong B2B experience in the chemical, materials or other related industry.
• Experience with new business development skills are required.
• Must possess basic financial understanding.

Compensation will include base, bonus, and stock options.

Director of IDN Sales/Development

Our client, a well known one billion dollar manufacturer of Medical Devices seeks a Director of IDN Sales/Development.  This individual will coordinate and direct corporate Integrated Delivery Network (IDN) strategy to include measured targeting of IDN opportunities.  Development of “value” proposition, in conjunction with Marketing, aimed at the Executive component of Integrated Development Networks and Regional Purchasing Coalitions.  In concert with Hospital Care, GPO and Distribution selling teams, coordinates activities around target IDNs while identifying and coordinating Executive alignment between the company and IDN prospect.  Identifies optimal targets, builds internal consensus around targets, and implements strategy in effort to accelerate revenue and profitability.  Works collaboratively, where strategically appropriate, across divisions to generate comprehensive ‘Enterprise’ offering in an effort to strengthen overall market position. 

Responsibilities: Essential Duties:

• Qualify and target key Integrated Delivery Networks.
• Creative development of Executive Level’ value messaging built on the strength of company products and services.
• Enhance and develop relationships with Integrated Delivery Networks, Regional Purchasing Coalitions and Accountable Care Organizations.
• Indirect management responsibility for all field sales managers/representatives regarding IDN issues.
• Analyze opportunities and create strategies to achieve mid-term and long-term IDN objectives.
• Prepare and negotiate new IDN contracts to increase and strengthen market position.
• Communicate and update key IDN contracts to increase and strengthen market position.
• Communicate and update key IDN initiatives to Field Sales, Sales leadership and Executive Board on a continuous basis. 
• Interface with corporate colleagues and inter-corporate partners to identify and capitalize on new opportunities.
• Work cooperatively with internal Distribution team to develop joint targeting efforts in cooperation with key distribution partners.
• Evaluate existing pricing strategies for target IDNs and develop comprehensive offering based upon cross divisional opportunities, market conditions and product mix.

Required:

• Bachelor’s degree.  Five (5) years sales management experience required.
• Ten (10) years of professional/sales experience in the healthcare industry including a working understanding of Group Purchasing Organizations and Regional Purchasing Coalitions with developing understanding of Accountable Care Organizations.
• Knowledge of Acute Care Distribution.
• Understanding of ‘Executive Level’ negotiation with demonstrated competency.
• Track record of ‘Executive Level’ presentation experience.

Desired:

• Five (5) years National Accounts experience preferred.
• Established IDN relationships.
• Experience with Strategic Selling concepts (eg. Miller-Heiman).

Compensation includes excellent base and bonus program with total compensation package of $200K+ area. 

Vice President of Operations

Our client, a privately-held manufacturer is currently seeking a Vice President of Operations.

This financially-stable organization is poised for further growth and is actively seeking a Vice President of Operations to lead the company in becoming a world class manufacturer.  The Vice President will be a member of the senior management team and will be responsible for manufacturing, purchasing, shipping and receiving, maintenance, environmental and safety, scheduling and inventory.  The choice candidate will have an extensive understanding of and be fully committed to continuous improvement.  The ideal candidate will have strong leadership skills, work effectively with others to identify and resolve problems, be able to communicate concisely and effectively and be committed to developing subordinates in their professional growth and success.

Major responsibilities will include:

• Creating and implementing the long-term Operations strategy based upon best practices and standardized policies and procedures within functions
• Creating and monitoring measurable key productivity indicators for Quality, Productivity, Cost and Safety and any other indicators which are critical to the success of manufacturing
• Actively engaging in continuous improvement by encouraging, teaching, participating in, and supporting the Lean Six Sigma culture and tools
• Managing the manufacturing staff and related functions at the facility to ensure production is timely and cost effective. Ensuring balance is maintained across functions for proper execution of responsibilities in a professional environment
• Effectively interacting with cross-functional groups including sales and marketing, R&D, engineering and quality
• Supporting new product transition in development, including early pilot builds, design for manufacturability recommendations, service strategies, etc.
• Supporting and promoting on-going safety and environmental programs in the performance of all activities
• Reviewing production operations, applying knowledge of production processes and methods, machine and equipment capabilities and staffing requirements, to produce quality products
• Reviewing operating results as they affect production cost, making specific recommendations to result in cost reduction and profit improvement

Education, Experience, Skills and Abilities Required for Consideration as a Candidate:

• Must possess a Bachelors Degree in Management, Engineering or related field
• Possess seven to ten years of experience in multi-product manufacturing setting working with chemicals, adhesives and/or coatings
• Must have minimum of three years supervisory experience
• Must have experience working in small to mid-size companies in a manufacturing capacity
• Experience with Lean Six Sigma and Lean Manufacturing is required
• Must be certified as a Green Belt, or its equivalent
• Must possess strong verbal, written, and interpersonal skills
• Must demonstrate strong leadership skills

Education, Experience, Skills and Abilities Preferred:

• MBA or equivalent
• Black Belt certified
• Project Management Training
• One to three years experience with ISO:9001
• Willingness to travel away from home for more than one day

Compensation will include an excellent starting salary, benefits, profit sharing and Healthcare programs. 

Director of Retail Marketing - DME

Our client a leading Chicago area based healthcare company is seeking a Director of Retail Marketing – DME.

• Objectives for the position:
• Grow DME retail business 20% per year for the next 3 years
• Provide leadership, strategy and sales support on DME retail business across various types of customers:
• Mass market retail: General merchandise and chain drug
• Drug wholesalers
• Dot.com customers
• Canadian retail
• Accelerate rate and quantity of new product and program development (fixtures, selling tools, bundles, etc) and introductions for types of customers above
• Strategically identify, prioritize and implement new product category opportunities
• Strategically identify and prioritize new retail distribution opportunities
• Drive penetration of these new distribution opportunities by working with, pushing and supporting our retail team and targeted HME sales managers

• Scope of responsibilities
• End to end product development (concept, costing, working with factories, packaging) for retail focused items
• Providing leadership with retail group in charting sales strategy/priorities and ensuring we execute on the implementation of that strategy
• Making sales calls to targeted retailers with retail sales group and target Healthcare sales reps/managers to sell retail opportunities and gain market intelligence
• Develop customer specific marketing plans for top 5 customers and top 3 growth prospects
• Be the project manager on key retail projects and initiatives to ensure success
• Work closely with respective product managers to ensure coordination and maximum impact of products and programs across channels

• Responsibilities/projects for next 120 days
• Develop and implement dot.com marketing program (including dot.com specific products and promotions) to drive $ 1.5 million of incremental sales in 2010
• Develop and implement drug wholesaler specific marketing programs to drive $1 million of incremental sales in 2010
• Lead development of 2010 Canadian promo for HME market
• Implement Walgreens profit optimization program and new products
• Identify objectives and implement consumer research
• Lead the growth of the WHI business by working with reps managing the key accounts and promoting the new pricing agreement
• Sell Cast Protectors into retail (non dealer) with a total of 500 stores
• Support K-Mart test to maximize success and future rollout
• Develop 2010 product and promotional plan for Costco.com
• Develop a plan for how we maintain our leadership position in rollators and transport chairs. Areas for consideration (not mutually exclusive)
• Smaller packaging
• Lighter weight
• More contemporary design
• Additional features
• Engage industrial design firm as appropriate to help design against prioritized goals

• Required skill set
• Strong marketing acumen
• Strong (persuasive, credible) in front of customers, including senior people at national retailers
• Strong project management
• 5-7 years experience in marketing with strong sales orientation

Experience in/around retail marketing (not necessarily DME, but preferred) strongly preferred

This company offers a business casual, entrepreneurial work environment with strong growth potential; a competitive compensation package; along with a complete benefits package including medical/dental/vision/life insurance; and 401(k) with company match. 

Regulatory Affairs Specialist

Our client, a well known North Carolina based manufacturer of Medical Devices and Biotech related products seeks a Regulatory Affairs Specialist.  This position reports to the head of Regulatory and Quality. 

Job Summary: Plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines.  Coordinates and prepares regulatory submissions, including 510(k) premarket notifications, EU MDD Technical Files and other international registrations.  Ensure compliance to all US, EU and international requirements (primarily EU, Asia and Canada) and company policies and procedures regarding submissions and other requirements for market approval of medical devices. 

Duties and Responsibilities:

• Provide regulatory support to new product development teams to ensure that US and other international regulatory requirements are incorporated as part of the development process.
• Author submissions and other regulatory documents to obtain approval to bring new or modified products to market.
• Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding presubmission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
• Support marketing, new product development and operations in regulatory assessment of proposed changes.  Perform and document regulatory assessments for modifications to existing devices.
• Interface and coordinate with FDA and other regulatory agencies on submissions, approvals or other issues.
• Interpret existing and/or new regulatory requirements as they relate to company products and procedures.  Communicate this to appropriate personnel.
• Prepare and update US product listings and establishment registration.
• Review labeling and marketing materials for compliance with global regulations; recommends appropriate changes.
• Prepare and maintain Technical File and Design Dossier to support CE Mark for EU products.
• Prepare and maintain international product registrations.
• Monitor activities/publications of FDA and international regulatory bodies to identify and respond to new or revised regulatory requirements.

Education, Experience, Skills and Abilities Required for Consideration as a Candidate:

• Bachelor’s Degree in a technical or scientific field
• Minimum 3 years experience in medical device regulatory affairs
• Strong interpersonal, written, oral, communication, organizational and planning skills
• Knowledge of PC systems and desktop office applications
• Sound understanding of scientific principles
• Ability to interpret regulatory requirements and communicate them to technical functions within the company
• Ability to work effectively as a member of a team
• 510(k) submission experience (has to have domestic)
• Strong research and analytical skills
• Ability to manage multiple projects

Education, Experience, Skills and Abilities Preferred:

• Professional certification RAPS or RAC
• Experience with US Class II medical devices (there are I, II,III classes – must have at least II)
• Experience with EU Class II medical devices
• Ability to interact with individuals in scientific and/or technical fields
• International device registration experience (preferably EU, Canada, Asia, etc.)
• Ability to effectively negotiate and balance the need for regulatory compliance with the needs of the business

CEO

Our client, a well-known billion dollar Chicago based Venture Capital firm is seeking a CEO with Healthcare, Biotech or Pharmaceutical experience.  This person will add to their bench strength which will allow them to buy or build a company around the successful candidate.  The individual they are seeking has a proven pedigree, a track record of building successful companies, and growing profitability. 

This Venture Capital experience allows them to add value to their portfolio companies through strategy development, operational guidance, and sharing of best practices.  In addition they assist with financing, acquisition and other capital market transition to improve profitability and revenue.  They look to invest $20 million to $300 million equity in each opportunity.

The successful individual will have managed a company with $10 million - $100 million in revenue with EBITDA of $5 million - $25 million range.  They are looking to build relationships with executives who can be value-added partners.