Regulatory Affairs Project Manager

The Company:

A leading company in the orthopedic market for internal fixation devices. This company develops, manufactures and markets the AO ASIF system of orthopedic instruments and implants, which are used by surgeons to internally repair difficult bone fractures.

Scope of the Job:

Provide primary regulatory assistance for assigned projects.

Responsibilities:

1. Prepare and submit pre-market approval (PMA), pre-market notification (510(k)), humanitarian device exemption (HDE), investigational device exemption (IDE), biologics license application (BLA), and submissions to the FDA.

2. Develop and propose regulatory strategies in cooperation with Product Development, Manufacturing, etc. for new and modified products.

3. Assist in the development and management of clinical trials and clinical trails strategies.

4. Review Document Change Orders (DCO) for compliance with regulatory requirements.

5. Work cooperatively with Product Development groups to understand regulatory requirements.

6. Regulatory records retention (update electronic regulatory archives with all cleared and /or approved regulatory submissions).

7. Maintain regulatory database.

8. Review proposed product labeling

9. Obtain and maintain Certificates to Foreign Governments and Certificates for Export.

10. Transmit Medical Device Listing information to appropriate parties.

11. Review trade publications for regulatory news (Federal Register, Gray Sheet, Etc.)

12. Manage the progression of PD projects to ensure the regulatory needs are met.

13. Coordinate and conduct meetings with FDA staff, as necessary.

14. Monitor FDA requests for additional information associated with submissions.

15. Assist as necessary in FDA compliance inspections (BIMO, QSR, Pre-approval)

16. Other duties as assigned.

· Minimum 5 - 7 years of medical device regulatory affairs experience.

· Demonstrated knowledge of U.S. Food, Drug and Cosmetic Act as amended.

· Demonstrated knowledge of FDA medical device regulations.

· Minimum BA/BS degree from an accredited four year college or university.

Additional Experience:

· Working knowledge of Microsoft Office software products

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· Demonstrated close attention to detail.

· Strong communication and interaction skills.

· Strong written and oral communication skills.

· Must be flexible, cooperative, and team oriented.

Compensation