Job Title: Regulatory Affairs Associate II
Location: San Clemente, CA 92673
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 reasonings.
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Location: San Clemente, CA 92673
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 reasonings.
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