- Location: California, United States
- Type: Contract
- Job ID: 10528
- Work Setting: On-Site
- Posted: August 10, 2026
- Closing Date: March 27, 2027
- Tax Status: W2
Senior Regulatory Specialist
6-Month Contract with Possible Extension
Onsite in Alameda, CA
Must be able to work on a W2
Requirements
- Conduct regulatory change assessments for medical devices.
- Support U.S. medical device submissions and regulatory activities.
- Participate in continuous improvement activities, product plan development, and implementation.
- Support the development and execution of regulatory strategies.
- Participate in risk management, regulatory policy, and regulatory intelligence activities.
- Ensure timely regulatory approval of new medical devices and continued approval of marketed products.
- Serve as the regulatory representative on cross-functional teams.
- Advise development and marketing teams on manufacturing changes, product line extensions, and technical labeling.
- Provide guidance on applicable medical device regulations and regulatory interpretations.
Qualifications
- Minimum of 5+ years of experience in Medical Device Regulatory Affairs.
- Extensive experience conducting regulatory change assessments.
- Working knowledge of U.S. medical device submissions.
- Experience supporting regulatory strategy, risk management, regulatory policy, and regulatory intelligence activities.
- Experience working cross-functionally with development, marketing, manufacturing, and other internal teams.
- Strong knowledge of medical device regulations and regulatory requirements.