Regulatory Affairs Manager
Company Summary:
My client, a rapidly growing medical device company focuses on delivering personalized solutions for cancer patients using 3D printing and personalized surgical planning. My client is looking to add a Regulatory Affairs Manager to their team! This role is located in Parsippany, NJ!
The Regulatory Affairs Manager will be responsible for:
- Working closely with the product development ream and identifying regulatory submission strategies to support regulatory submissions
- Determining product classification and assembling the corresponding technical documents
- Authoring pre-submissions for FDA feedback on regulatory strategy and participating in project meetings with product development teams to execute the identified regulatory strategy
- Preparing comprehensive marketing submissions (510k, Technical Documents, Design Dossiers, De Novo, etc.)
- Reviewing labelling and promotional materials to ensure regulatory compliance
The Regulatory Affairs Manager should have the following qualifications:
- 7+ years of experience in medical device regulatory, quality or development roles and BS in scientific discipline
- 5+ years of experience in international Regulatory Affairs/Compliance
- Strong knowledge of current US/international medical device regulations
- Experience communicating with the FDA
