Regulatory Affairs Supervisor

Job Summary - Supervise compliance with U.S. Food and Drug Administration (FDA) device and drug registration, listing, and pre-market requirements for Company marketing products in the U.S. Supervise compliance with U.S. FDA requirements regarding export of products from the U.S. Maintain contact with appropriate regulatory agency departments. Oversee compliance with departmental documentation procedures. Responsibility for Compliance Database and Controlled Documents. Maintain all applicable files, databases and records. Update and follow company CAPA policies and procedures

Duties and Responsibilities

1.  Supervision and maintenance of the Otto Bock Americas CAPA program and policies.  Train Company personnel on complaint handling and CAPA policies and procedures.

 

2.Preparation of regulatory submission cover letters, arrange teleconferences and meetings with regulatory agencies and produce comprehensive meeting minutes.

 

3. Develop and Maintain databases to support FDA activities and regulations. 

 

4. Supervise and monitor all FDA recalls, field corrections and related product matters.   

 

5.  Closely monitoring daily FDA information release and other identified sources to maintain an up to date understanding of FDA’s position on all aspects of medical device development and market introduction requirements including the analysis and summary of new FDA guidances and other regulatory obligations of the company.  

 

6.  Provide general project supervision and coordination of regulatory affairs to insure availability of documents and company information in the preparation and support of the submissions of 510 K’s including 510 K memos to file updates and other required submissions that may be required of the company as it enters products into various classifications.

 

7.  Interact with various Development groups in the company to assure compliance with FDA regulations.

 

8.  Interact closely with FDA and other regulatory authorities, including EU health agencies and Health Canada.