Regulatory Affairs Associate

Job Title:
Regulatory Affairs Specialist

Location: Santa Clara, CA (100% Onsite)

Duration: 12 Months (Contract)

Pay Range: $41/hr – $46/hr (W2)

The Regulatory Affairs Specialist is responsible for managing regulatory submissions and government interactions related to products requiring regulatory approval.

• Author, prepare, and submit PMA supplements, including 30-Day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports.

• Serve as the primary point of contact with the FDA and other regulatory authorities.

• Ensure compliance with FDA PMA guidance documents and 21 CFR regulations.

• Provide regulatory strategy input and support cross-functional teams.

• Bachelor’s degree required; advanced degree preferred.

• 5–8 years of direct Regulatory Affairs experience in medical devices.

• Recent experience with Class III implantable medical devices.

• Strong knowledge of FDA PMA processes and CFR regulations.

We are looking for the candidate who are eligible to work with any employers without sponsorship

If you’re interested, please click “Apply” button

Manpower Group is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of Manpower Group and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.