Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
We're hiring a Senior Regulatory Affairs Specialist to support U.S. and global regulatory submissions for medical devices and partner with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
Key Responsibilities
- Prepare and support submissions including IDEs, 510(k)s, CE Technical Documentation, UKCA, and global registrations
- Maintain regulatory approvals and submission documentation
- Review design control documents, labeling, and quality system procedures
- Support regulatory agency interactions and responses
- Collaborate with R&D, Quality, Clinical, and Marketing teams
- Monitor regulatory changes and competitor activities
- Assist with SOPs, process improvements, and post-market activities
Qualifications
- Bachelor's degree in a scientific or engineering discipline
- 4+ years of medical device Regulatory Affairs experience
- Experience with FDA and international regulatory submissions
- Knowledge of FDA regulations, Design Controls, ISO 13485, and global medical device requirements
- Strong communication, organization, and project management skills
Additional Information
Hybrid role based in Alameda, CA
10-30% travel as needed
No current or future visa sponsorship available
Equal Opportunity Employer
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