More jobs:
Regulatory Affairs Associate
Job in
Santa Clara, Santa Clara County, California, 95053, USA
Listed on 2026-02-12
Listing for:
ManpowerGroup Global, Inc.
Contract
position Listed on 2026-02-12
Job specializations:
-
Healthcare
Healthcare Compliance -
Government
Job Description & How to Apply Below
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.
Key Responsibilities- 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
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×