Summary of Position with General Responsibilities:

This position manages the domestic (U.S.) and international activities of related product lines for the Regulatory Affairs department according to our corporate procedures and policies; U.S. Government policies, primarily the Food and Drug Administration (FDA); applicable State requirements; and European and international regulations and standards.

This position coordinates domestic and international submission preparation and approval and FDA or appropriate international body in a timely manner. Responsible for determining RA strategies for our relevant products. This position must recognize potential regulatory issues in our day-to-day activities that involve product development through the manufacturing process.

Essential Job Functions:

 1. Performs supervisory responsibilities for direct reports, including but not limited to, performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions and disciplinary actions.

2. Identifies development needs and potentials of employees, and provides or recommends project assignments and training to increase expertise to meet current or future division needs.

3. Provides technical support and feedback for direct reports.

4. Responsible for general oversight of related product lines and participates in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements.  Develop, document and implement regulatory submission plans around product development/line extension goals.

5. Makes preliminary determinations regarding the appropriate U.S. regulatory submission requirements for new or modified products.

6. Prepares U.S. FDA 510(k), IDE, PMA and export submissions as required.  Ensures that all submissions are accurate and completed in a timely manner.  Ensures that all arguments presented in the submission are appropriate, defendable and scientifically based.

7. Prepares and updates European and international product dossiers/registrations as required.  Ensures that all submissions are accurate and completed in a timely manner, and that all arguments presented in the submission are appropriate, defendable and scientifically based.

8. Provides labeling, recall and FDA inspection assistance; ensures compliance with PMA change control and reporting requirements, as defined by corporate and our procedures.

9. Reviews all clinical and marketing study protocols for compliance with FDA, European and international regulations and standards.

10. Reviews Engineering Change Orders for compliance with FDA, European and international regulations and standards.

11. Coordinates the review of FDA submissions and labeling by our Corporate Regulatory and Medical Affairs, and the Legal Department.

12. Keeps knowledge of FDA requirements current by attending industry, FDA and Corporate seminars, when possible.

Additional Desirable Qualifications Skills and Knowledge:

High analytical evaluation skills.
Good negotiation skills.
Demonstrated positive communication and human relation skills.
Excellent communication (both verbal and written)
Excellent people and project management skills, with ability to prioritize and delegate, handling several projects concurrently.
Proficient in Windows environment.

Education and/or Experience:

 Bachelor's Degree in Life or Engineering Science

Six to eight years experience as a multi-functional Regulatory Affairs professional or equivalency.

A minimum of three years experience in a supervisory capacity. 

Comprehensive knowledge of U.S., European and international regulations and standards covering medical devices.

Knowledge of the clinical application of medical devices, as applicable.

Knowledge of medical device testing methods and statistics, as applicable.

Prefer RAC certification