• Director of Quality & Regulatory
• Product Marketing Manager
• Clinical Manager
• Area Vice Presidents
• New Product Development Engineer
• European Key Account Manager

Director of Qualty & Regulatory

As we discussed, I am currently seeking a Director of Quality & Regulatory for a well known $150 million Chicago based manufacturer of Healthcare Products.  This individual will design and implement a Total Quality Management system for the U.S., Canada, Mexico, and Latin American business, to ensure supply and distribution of products in conformance with all local regulatory, business, and customer requirements, by performing the following duties personally or though subordinate supervisors and staff.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned.

• Prepares, or directs consultants in preparation, of required regulatory filings, including 510k for U.S. FDA approval.  Works to ensure required registration of products for all countries in which they operate.

• Develops and maintains quality system to comply with U.S. FDA Quality System regulations and international ISO 9002 requirements.

• Train and direct technicians engaged in inspection and testing activities at remote facilities to ensure continuous control over materials, facilities, and products.

• Formulates and monitors quality measurements and objectives and coordinates CAPA and quality improvement efforts throughout the company in cooperation with other managers to maximize product and service reliability and operational efficiency and effectiveness.

• Leads Complaint Review Meeting and Quality System Review meeting; manages relationship with external quality auditors; facilitates cross-functional problem solving and quality improvement teams.

• Design and conducts training activities related to quality and regulatory.

• Investigates and responds to issues of customer complaints regarding product quality.  Manages complaint reporting and analysis process and coordinates internal and external activities related to CAPA.

• Works closely with manufacturing facilities, as well as other product and parts suppliers to ensure compliance with company’s quality system and regulatory requirements.

SUPERVISORY RESPONSIBILITIES

Manages exempt and nonexempt employees in the Quality Department.  Is responsible for the overall direction, coordination, and evaluation of this unit.  Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws.  Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complains and resolving problems.

EDUCATION

B.S. or B.A. in engineering or related technical discipline; Certified Quality Manager (CQM) or Certified Quality Engineer (CQE).

EXPERIENCE

Five to seven years related experience in Quality / Regulatory Management in an FDA-regulated environment.

Product Marketing Manager

A leading Chicago based Consumer Products Healthcare company is currently seeking a Product Marketing Manager Canada.  This individual will develop, implement and control product marketing plans and trade marketing plans that are linked to the strategy and supported by marketing research or consumer insights for the Canada region.

Essential Duties and Responsibilities include the following:

Create and develop comprehensive marketing plans for existing and new products across all categories in conjunction with the product marketing team.  Marketing plans will include: market analysis of the company and competitive products and strategies; product and market analysis of strengths, weaknesses, opportunities, and threats; defining objectives that are consistent with long-term growth and profitability goals; development of strategies and tactics to achieve financial goals, and formulation and coordination of promotional programs.

Launch new products, which will include: understanding customer and sales force needs via effective market research; product definition and development; translating research results into viable new products, line extensions, and/or product launches by market segment; developing product training materials for customers and staff; evaluating customer and sales force feedback on products; and providing marketing input to product development teams to define customer functional requirements.

Create plans for all product lines in Canada, including driving annual and strategic mid-term planning process; providing vision and establishing long-range goals; preparing operating plans to include sales forecasts and expense budgets; and supporting forecasts and budgets with appropriately detailed marketing plans. 

Enhance sales/profit and manage cost recovery, including: analyzing sales trends and impact of competitor products; reviewing and analyzing monthly sales performance; offering proactive solutions to detrimental sales trends; reviewing all levels of production cost and working actively towards lowering them; and managing inventory to optimal levels by identifying and taking action on slow-moving or obsolete products and/or parts. 

Support the Sales and Consumer Services functions by: working regularly with Sales in their accounts and at trade shows; meeting regularly with Sales staff; developing and executing trade marketing plans; supporting Sales through support and information to Customer Services; communicating new product information, product availability, inventory status, pricing updates, and competitive information to Sales force.

Education

Bachelor’s degree from four-year college or university, or equivalent experience; MBA preferred.

Experience

Three to five years related marketing experience.  Experience in Canadian retail markets preferred.

Compensation

Clinical Manager

Our client, a well known Chicago based manufacturer of Medical Devices and Pharmaceutical Products seeks a Clinical Manager to ensure the development and commercial production of products, Class II and III medical devices and pharmaceuticals, complying with QSR, ISO13485, cGMP, GLP, GCP and other relevant requirements.  Perform the preparation and completion of all clinical studies in cooperation with Investigators, CRC and CRO, data management, data analysis and document preparation related clinical study to be submitted to FDA and collaboration with R&D, Engineering, RA and QA team.  Also take initiative and facilitate the promotional clinical case studies (open studies) as well as RCT (randomized control trial) type studies for company’s products.

Principle duties:

• Take initiative and leadership and facilitating all product clinical studies
• To investigate regulatory guidelines and requirement for clinical study in collaboration with RA manager, regulatory consultants and CRO’s.
• To develop clinical protocols, packaging and labeling for investigational product in collaborating with R&D, Engineering, RA and QA team.
• To coordinate study meetings with investigators and CRC in cooperation with CRO.
• To educate and train clinical investigators in cooperating with CRO to comply with GCP, ICH and other regulatory standard.
• To communicate with and reply to FDA regarding investigational clinical studies in order to obtain FDA approval.

• Supervising monitoring activity and data management and analysis in clinical study
• To take responsibility of supervising monitoring activity of CRO performed at clinical sites.
• To take responsibility of supervising clinical data management and analysis handled by CRO.
• To take initiative to coordinate DMC meetings periodically and/or according to the request by DMC members.

• Taking initiative and leadership and facilitating to establish internal system complying with GCP, ICH and other regulatory standard
• To educate and train internal CRA to comply with GCP, ICH and other regulatory standard.
• To take responsibility of archiving clinical study documents.

Job Responsibilities:

This position reports to Director, Product Development and Technology.  To establish enough knowledge about the company’s products to manage clinical studies.  To establish a good communication with Investigators, CROs and FDA.  To enable 1-2 week business trip to inside or outside of the U.S.

Requirements:

BS or higher.  A minimum of 5 years clinical study managing experience in pharmaceutical or medical device, including a substantial handling PMA.  Basic understanding and experience in biostatistics.  Good at English writing and editing for regulatory documentation using Word, Excel, PPT, etc.

Compensation includes base, bonus is flexible depending on experience.

Area Vice Presidents

A Global Skincare Company expanding their presence in the USA, are looking for two Area Vice Presidents to help split up the country. 

This person will be responsible for working with both acute care and long term care markets.  They will call on the IDN’s, major GPO’s, national accounts (hospital and nursing home chains), and major distributors (PSS, Cardinal, McKesson and Owens & Minor) in their area.

This individual must have a proven track record selling Healthcare products and managing relationships with these areas.  Additionally, they need to have a strong IDN background to help drive these products up to the GPO’s.

The successful candidate will have strong selling and negotiating skills, excellent communicator, ability to work in a team environment, drive results by influencing others, along with excellent leadership skills and ability to motivate teams.  Additionally, should be able to make sound business decisions under pressure and be able to make strong group presentations.

Compensation will include a base of $140K+ along with bonus, car allowance and benefits, and flexible depending on experience.

New Product Development Engineer

Our client, a well-known manufacturer of Medical Products, seeks a New Product Development Engineer.  This person will be responsible for developing products, processes and technologies, which increase sales and improve profitability and product quality.

Duties and Responsibilities:

• Understands and adapts to market needs for new products.
• Identifies and evaluates new materials, components and technologies.
• Leads and participates in multidisciplinary product launch teams.
• Adheres to Design control and Stage gate processes.
• Documents activities, experiments, trials, samples and ideas in a research laboratory notebook.
• Updates project progress to key stakeholders.
• Documents and keeps records for all project proposals, activities, experiments, trials, samples, ideas, etc. for future reference.
• Understands Patent positions of new and/or existing technology.
• Prioritizes activities with manager and business team and direct efforts accordingly.
• Accurately scopes time and budgets of projects.  Completes projects on time and within budget.
• Organizes, executes and reports in depth technical evaluations of competitive products.
• Actively works to transfer design to manufacturing at the appropriate time.
• Responsible for producing product samples.
• Must be knowledgeable in the effective use of Lean Six Sigma (LSS) tools and concepts to assist in process improvements.

Ideal candidate will have a minimum of 3 years in New Product Engineering within Medial or Bioscience products.  Additionally, this person should have a BS in Science, Engineering, or Technology. 

Compensation is flexible depending on experience.

European Key Account Manager

Our client, a well-known manufacturer of BioProcessing Products, seeks a European Key Account Manager.  This individual will assist in determining the director as well as commercial and manufacturing strategies primarily for the European bio processing business. Direct and manage commercial activities required to establish company’s position in the European BioPharmaceutial market.  This position will coordinate all activities with all other business functions to executive business plans and market advancement. 

Duties and Responsibilities:

• Will provide company’s initial introduction to the European community and establish key relationships.
• Develops, writes and implements European business plan and budgets based on market knowledge and overall business performance criteria.  These plans will include strategic directions and milestones as accountable party. 
• Prepares and manages annual budgets for the sales activities of the business.
• Establishes European pricing policy and communicates it to the organization.
• Responsible for analyzing and articulating customer needs, developing relationships with key customers, and managing key accounts.
• Will work in concert with NPD and staff to develop short and long term New Product Development requirements to meet strategic and tactical goals of the European business. Oversees and analyzes sales forecasting and adherence to current yearly plans.  Develops and manages contingencies for plan changes.
• Maintain systems to predict and monitor competitor behavior.
• Manage or balance long-term supply and demand by using sales forecasting systems and facility expansion.
• Identify new business opportunities, evaluate and develop as appropriate.
• All other duties as assigned by the President.

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

• B.S. degree in Business, Marketing, or related degree required.
• Must have five plus years of experience in both sales and marketing. Must possess excellent verbal, written presentation skills.
• Must be capable of playing a strategic and tactical role in serving as a catalyst and leader within the company.
• Should demonstrate the ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or regulations. Ability to write reports business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions form groups of managers, clients, and customers.
• Negotiation and conflict management skills are preferred.
• Must possess basic financial understanding.
• Experience with new business development skills is a plus.
• Progressive management responsibilities.
• Bi-lingual.

Compensation will include a base, bonus, car, healthcare benefits and is flexible depending on experience.