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Regulatory Affairs Specialist
Job in
San Clemente, Orange County, California, 92674, USA
Listed on 2026-03-01
Listing for:
Acro Service Corp
Full Time
position Listed on 2026-03-01
Job specializations:
-
Healthcare
Healthcare Compliance
Job Description & How to Apply Below
🔔
Now Hiring:
Regulatory Affairs Associate II
We are seeking a Regulatory Affairs Associate II to support medical device regulatory activities
, with a strong focus on EU MDR compliance
. This role plays a key part in ensuring regulatory readiness and successful submissions across global markets.
- Preferred:
Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or a related field
Candidates should have experience with:
- Medical Device Regulatory Affairs
- EU MDR remediation activities
- Regulation (EU) 2017/745
- Technical Files / Technical Documentation
- GSPR (General Safety & Performance Requirements)
- 510(k) submissions
- Interaction with FDA and/or Notified Bodies
- ISO 13485 Quality Management Systems
- EU MDR compliance initiatives
- Support preparation and maintenance of EU MDR Technical Documentation
- Assist with regulatory submissions and remediation projects
- Collaborate with cross-functional teams to ensure compliance
- Interface with regulatory authorities as needed
📩
Interested candidates or referrals are encouraged to apply.
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