Regulatory Affairs Manager - 510(k) focus
FPCNational - Minnesota

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Regulatory Affairs Manager sought for a successful mid western pharmaceutical company expanding its recently developed medical device product focus.

The Top Challenges:
1) Ensure global compliance of submissions, registrations, technical files, labeling (claims), and marketing materials of a new and growing medical devices product line. Included in this will be:
a. Leading the preparation and submission of 510(k)’s to the FDA as well as device licenses to Health Canada
b. Leading the preparation of technical files for CE registrations
2) Regulatory Strategy coordination
3) Manage the final product submissions and negotiate and communicate effectively with regulatory authorities to obtain timely product approvals
4) Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products
5) Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes and products
6) Review materials such as labeling, marketing literature, packaging, websites and social media to ensure that regulatory risk is mitigated
7) Participate in the development and implementation of stability protocols. Further, review stability data to ensure that desired outcomes are obtained.

Longer Term Challenges:
8) Expand regulatory focus to include existing OTC, cosmetic and supplement product lines.

Location : Midwest city
Contact: Apply below and/or at and/or contact Ira Mann at

1) 5+ years of regulatory affairs experience in Medical Device industry.
2) B.S. degree.
3) Relocation package is included however you must have the desire and ability to live in a Mid Western city as well as understand the working of a small company environment.
4) Strong 510(k) submission experience

5) Experience in BOTH Medical Device and OTC Pharmaceutical
6) Preparation/submission of drugs and device licenses in Canada (strongly preferred)
7) ROW and/or CE experience
8) Repackaging and labeling experience
9) Stability protocol experience

Key Words: 510(k), Health Canada, CE mark, regulatory submissions, regulatory strategy, stability protocol, repackaging, labeling