Successful Medical Device Manufacturer is growing and is in need of an experienced professional to lead and manage as Regulatory Affairs Program Manager.

This position manages the domestic (U.S.) and international activities of related product lines for the Regulatory Affairs department according to 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 by Corporate, and FDA or appropriate international body in a timely manner. Responsible for determining RA strategies for relevant products. This position must recognize potential regulatory issues in day-to-day activities that involve product development through the manufacturing process.

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.

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.

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

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.

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.

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

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

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

Qualifications:

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