Senior Regulatory Affairs Specialist

Job Description

Job Description

POSITION: Senior Regulatory Affairs Specialist
LOCATION: Union City, CA
WORK SCHEDULE: Full-Time | Onsite

Our client is seeking an experienced Senior Regulatory Affairs Specialist to join our team and play a key role in supporting regulatory operations across the company. In this role, youll be responsible for preparing and submitting regulatory documentation for both U.S. and international markets, ensuring compliance with applicable FDA regulations and global standards.

Please note that this is a full-time, onsite position located in Union City, CA. No remote or hybrid work will be allowed for this role.

Responsibilities:

• Prepare, compile, and submit regulatory documentation, including technical files, annual reports, amendments, supplements, and more.

• Support U.S. and international product registrations, including post-market regulatory requirements.

• Maintain and update the regulatory database, ensuring accurate submission tracking and compliance.

• Assist with the development and maintenance of SOPs, protocols, and reports to align with FDA and global regulatory standards.

• Coordinate responses to regulatory authority inquiries and prepare briefing documents as needed.

• Support licensing requirements and renewals with state and regulatory agencies.

• Stay current on relevant industry trends, laws, and medical device regulations.

• Collaborate cross-functionally to align regulatory strategies with company goals.

• Organize and prioritize tasks to meet deadlines on time-sensitive assignments.

Requirements:

• Bachelors degree in a technical discipline (e.g., engineering, biology, chemistry, etc.)

• 810 years of experience in Regulatory Affairs, with at least 2 years in the Medical Device industry

• Strong understanding of FDA regulations (21 CFR Part 820), GMPs, and global regulatory standards

• Hands-on experience with international product registrations and post-market requirements

• Familiarity with regulatory requirements related to cybersecurity, wireless, and sterile medical devices

• Exceptional communication, time management, and organizational skills

• Ability to manage multiple priorities and collaborate with cross-functional teams

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)