Job Description
Job DescriptionJob Title: Sr. Regulatory Specialist
Duration: 6 Months Contract (Possibility of Extension)
Location: Alameda, CA 94502
Shift: 9:00 AM 5:00 PM
Job Description:
- Must have 7 years of experience in Medical Device Regulatory Affairs.
- Highly experienced in regulatory change assessments.
- Working knowledge of U.S. Medical Device Submissions.
- Experience with regulatory strategy, risk management, regulatory policy & intelligence, and continuous improvement activities.
- Ensures timely approval of new medical devices and continued approval of marketed products.
- Serves as a regulatory representative for cross-functional teams.
- Advises development/marketing teams on manufacturing changes, line extensions, technical labeling, and applicable regulations/interpretations.