Job Description
Sr. Regulatory Affairs Specialist
Location: SF Bay Area - East Bay - 5 days onsite
Compensation: $120,000 – $160,000 + 8% bonus
Type: Full-time, Direct Hire
Overview
We are seeking a Senior Regulatory Affairs Specialist to support U.S. and international submissions for medical devices. This role focuses on compiling, preparing, and submitting regulatory documentation, with emphasis on products involving software , wireless, cybersecurity, or sterilization .
Key Responsibilities
- Prepare, review, and submit regulatory submissions (510(k), technical files, amendments, annual reports) in the U.S. and international markets
- Maintain regulatory databases, product licenses, and documentation in compliance with FDA QSR (21 CFR Part 820) and ISO standards
- Support regulatory strategy, policies, and SOPs to ensure adherence to global requirements
- Interface with FDA, international authorities, and internal teams to resolve regulatory questions
- Collaborate cross-functionally to support product development, risk management, and compliance activities
- Stay current on regulatory trends, guidance, and global requirements
Qualifications
- Bachelor’s degree in Engineering, Biology, Chemistry, or related technical discipline
- 8–10 years in Regulatory Affairs, including at least 2+ years in medical devices
- Must have direct experience in at least one: software , wireless, cybersecurity, or sterilization
- Proven experience with international registrations and post-market submissions
- Strong knowledge of 21 CFR, FDA guidelines, GMPs, and ISO standards
- Excellent writing, communication, and project management skills
- Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Job Tags
Full time, Work at office,