Medical Device Quality Specialist

5 days ago


Blue Bell, Pennsylvania, United States Private Medical Device Company Full time
Requirements

We are looking for a highly organized individual with excellent communication skills and attention to detail. The ideal candidate will have 5+ years of experience in regulatory affairs and/or quality management, preferably in the medical device industry.

Required qualifications include:

  • Bachelor's degree in Engineering, Life Sciences, or a related field (Master's preferred).
  • Strong knowledge of regulatory standards, including FDA, ISO 13485, MDR, and other relevant medical device regulations.
  • Proven experience with regulatory submissions, including 510(k) filings, PMA, CE marking, and international submissions.


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