Regulatory Specialist Sr
Select Source International · Alameda, CA · 2 wk ago
On-siteLegalFull-time
Duration: 6 months (W-2) with possibilities of extension
Location: Alameda, CA 94502
About the role
We are seeking a highly experienced Regulatory Specialist with a minimum of 7 years in Medical Device Regulatory Affairs. The ideal candidate will be adept at regulatory change assessments and possess working knowledge in US Medical Device Submissions.
Responsibilities
- Participate in continuous improvement activities, product plan development and implementation, regulatory strategy, risk management, regulatory policy, and intelligence.
- Ensure timely approval of new medical devices and continued approval of marketed products.
- Serve as the regulatory representative to cross-functional teams.
- Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, and appropriate regulations and interpretations.