Senior Regulatory Affairs Specialist

Job Title: Senior Regulatory Affairs (RA) Specialist Location: Union City, CA
Industry: Medical Devices / Regulatory Affairs
Employment Type: Full-Time
Client: Lhasa OMS, Inc.

About the Role

Lhasa OMS, Inc. is seeking a highly motivated Senior Regulatory Affairs Specialist to join our team in Union City, CA. The ideal candidate will support the Regulatory Affairs department by preparing and submitting regulatory documentation for medical devices in both domestic and international markets. This position is an excellent opportunity for a detail-oriented professional to grow within a company known for its strong team culture and low turnover.

Key Responsibilities

• Compile, review, and submit regulatory submissions including Device Master Files, technical files, annual reports, supplements, and amendments for U.S. and international markets.
• Maintain and manage regulatory submission databases and tracking systems.
• Ensure compliance with applicable regulations, including 21 CFR Part 820, FDA guidelines, and relevant international standards.
• Support and maintain Device Manufacturing Licenses as required by regulatory bodies.
• Participate in the development and review of regulatory policies, SOPs, and protocols.
• Collaborate cross-functionally with internal teams to ensure timely regulatory submissions.
• Assist with regulatory responses and briefing documents for communication with global regulatory authorities.
• Stay up to date with changes in regulations, including those related to cybersecurity, wireless, and sterile medical products.
• Participate in regulatory training and apply updated knowledge to daily activities.

Required Qualifications

• Bachelor s degree in a technical discipline (e.g., Engineering, Biology, Chemistry, or a related field).
• 8 10 years of experience in Regulatory Affairs, with 2+ years in medical devices.
• Experience with U.S. FDA regulations (21 CFR) and Good Manufacturing Practices (GMPs).
• Proven success in international product registrations, post-market activities, and working with cybersecurity, wireless, and sterile products.
• Excellent communication, organizational, and time management skills.
• Strong computer proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Ability to manage multiple projects in a fast-paced, deadline-driven environment.

Work Environment

• Standard office environment using typical office equipment (computer, copier, phone).
• Noise level: Low to moderate.
• Reasonable accommodations can be made for individuals with disabilities.

Why Join Us?

• Competitive salary and performance-based bonuses
• Exposure to global regulatory strategy and government regulations
• Opportunity to build your reputation in a niche medical device field
• Supportive, low-turnover team environment