BioTalent
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 Bachelors degree in Engineering, Biology, Chemistry, or related technical discipline 810 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)
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 Bachelors degree in Engineering, Biology, Chemistry, or related technical discipline 810 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)