Senior Regulatory Affairs Specialist - Medical Devices

Irvine, CA

Full-time $105,000.00 - $130,000.00

Posted 05/14/2025

Senior Regulatory Affairs Specialist

Location: Irvine, CA
Salary: $105-130K depending on experience/education etc

Position Overview
The Regulatory Affairs Specialist is responsible for ensuring that Class II/III medical devices meet all regulatory requirements and standards throughout their lifecycle. This role involves the preparation and submission of technical documentation, as well as maintaining compliance with EU MDR and US PMA regulations.

Key Responsibilities

Prepare and submit technical documentation for medical devices in compliance with EU MDR and US PMA regulations.
Collaborate with cross-functional teams to ensure all regulatory requirements are met during product development and lifecycle management.
Conduct regulatory intelligence to stay updated on changing regulations and guidelines.
Support the development of regulatory strategies for new products and modifications to existing products.
Review labeling and promotional materials for compliance with regulatory standards.
Assist in preparing for and participating in audits and inspections by regulatory authorities.

Qualifications

Bachelor's or Master's degree in Life Sciences, Engineering, or a related field (e.g., Pharmacy, Biology, Microbiology, Chemistry)
3+ years Proven experience in Regulatory Affairs within the class II/III medical device industry.
In-depth knowledge of EU MDR and US PMA regulations.
Experience with technical documentation and product lifecycle management systems.

For this position you must be currently authorized to work in the United States. We do not sponsor for this position.

Additional ways to apply

Preferred Skills

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Employees will receive paid leave to the extent required by state or local law. This job was first posted by CyberCoders on 05/14/2025 and applications will be accepted on an ongoing basis until the position is filled or closed.

CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please contact a member of our Human Resources team to make arrangements.

Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.