Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
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)
Employment Type
Full Time
