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Regulatory Affairs Associate

ProKatchers LLC, San Diego, California, United States, 92189

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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.

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