Leads, manages and actively participates in the CDD Contract Services Regulatory organization, including Documentation, CAPA/DR Management, regulatory submissions and country registrations, export/import, with emphasis on quality in the areas of design, validation, manufacturing and support of all products produced by the CDD Contract Manufacturing sites.  Provide vision, goals, policies and procedures for the Regulatory organization that support the Quality Policy and the mission and goals of the CDD Contract Services business and Thermo Fisher Scientific.  Assure fulfilment of worldwide regulatory requirements.  Assure product design and quality meet the expectations of CDD Contract Manufacturing customers.  Act as Deputy Management Representative for all FDA, ISO 13485 and all other regulatory issues.  Provide direct interface with the FDA and all review authorities on regulatory submissions.

1. Establishes annual Regulatory Affairs (RA) goals and objectives for the CDD Contract Services sites.  Manages the preparation of financial, organizational, and facility plans for the RA department.

2. Maintains and improves the effectiveness of the Quality System.  Chairs CDD Contract Services Quality Management Reviews in order to determine effectiveness of the Quality System.

3.  Interfaces with applicable regulatory agencies and corporate divisions/departments, maintaining up-to-date knowledge of applicable regulations, standards and policies.  Maintains an in-plant program providing employee training and awareness of regulatory and quality policies and procedures.  Provides regulatory expertise and interpretation to personnel or in situations requiring such expertise.

4. Participates in the Core Team process in support of new product development efforts to ensure that both CDD Contract Services goals and objectives and customer expectations are met.  Serves as chairperson for the new product design reviews to ensure compliance with design controls and the products will meet customer's expectations.

5. Translates knowledge acquired with current products in the field into product and process improvements.

6. Oversees creation and maintenance of manufacturing documentation and product labeling.  Assists with generation of PSRs as related to shipping regulations (e.g. DOT, IATA, etc.)

7. Actively manages the CDD Contract Services relationship with the FDA and other regulatory agencies; leverages the relationship with the FDA and other agencies to eliminate delays in product clearances and approvals.  Oversees support for US and international country product registrations on a continuous basis including Certificates of Foreign Government and Certificates of Export; maintains the IEDB import/export database and ensures compliance with NAFTA and CAFTA requirements.  Maintains archives of quality and regulatory activities, programs, records and procedures for the CDD Contract Manufacturing sites.  Prepares 510K and/or PMA submissions for FDA approval on new products as required.  Acts as Deputy Management Representative during in-plant inspections by applicable regulatory representatives, as required.

8. Manages effective CAPA and discrepancy reporting (DR) systems including responsibility for any and all DFA reportable events and recalls.  Manages the database of Action items, CAPAs and Effectivity checks.  Chairs the Material Review Board and dispositions discrepancy reports; participates in the Change Order Review Board.

9. In conjunction with EH&S, represents signature authority for validation processes.

10. Motivates, develops, and retains a staff of skilled professionals who contribute to achieving the objectives and goals of the QA organization and the CDD Contract Services business.  Develops and maintains a flexible organization such that fast changing manufacturing priorities can be accomodated with a minimum of disruption and bottlenecks.

11. Performs other duties as assigned.

Minimum requirements/qualifications

B.A. or B.S. degree in Life Sciences discipline; M.S. or Ph.D. preferred.

Ten years experience in Quality Assurance/Regulatory is required, with at least five years of which have been in the management of a  scientific discipline.

Established positive relationships with the FDA and other regulatory agencies.

Prior experience in management of clinical trial activities for new products.

IVD industry experience is preferred.

ASQ certification or RAPS associate is preferred.

Non-Negotiable Hiring Criteria:

1. He/she must use  their educational, technical training, background and relevant industrial experience to enable a proactive and preventative approach to employee awareness and facility compliance and quality systems.

2. He/she makes independent decisions on regulatory and quality issues and has authority to require compliance to regulatory and quality policies.

3. Position requires a high degree of independent prioritization, review and approval of work.

4. The incumbent must have thorough working knowledge of Quality assurance principles and regulations including Good Laboratory and Good Manufacturing Practices and broad understanding of technical aspects, as applicable to a medical device manufacturing facility.

5. He/she must be knowledgeable in the diverse operations of Diagnostics Quality Assurance, Regulatory, and Manufacturing Operations and be able to relate these to applicable regulations and implement compliance through superiors, peers and subordinates.

6. He/she must be able to communicate clearly and effectively with internal and external contacts, superiors, peers and subordinates.

7. He/she must review practices, systems and needs, relate these to current regulatory requirements and implement changes or programs to achieve compliance.