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)

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