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Regulatory Affairs Associate
Job in
San Diego, San Diego County, California, 92189, USA
Listed on 2026-03-01
Listing for:
ProKatchers LLC
Full Time
position Listed on 2026-03-01
Job specializations:
-
Healthcare
Healthcare Compliance
Job Description & How to Apply Below
Job Title:
Regulatory Affairs Associate II
Duration: 12 Months
Pay Range: $32/Hourly! - $35/Hourly!
Job Description:
- Direct medical device regulatory experience (no pharma/biotech-only backgrounds) with recent hands‑on EU MDR 2017/745 experience (GSPR, MDR remediation/compliance, Technical Files), 510(k) exposure, FDA and/or Notified Body interaction, and ISO 13485 familiarity.
- Bachelor’s Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
- RAC Certification preferred.
- A minimum of two years of experience in Medical Products Industry in Regulatory Affairs.
- Able to assess scientific arguments and apply analytical and logical reasoning.
Position Requirements
10+ Years
work experience
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