Job Details

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 softwarewireless, 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: softwarewireless, 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)