Quality Regulatory Manager

1 month ago


Beverly, United States BioTalent Full time

BioTalent is partnered with a medical device manufacturer focusing on next-generation technology focusing on laser and imaging tech. You will be focused on the production of class III devices while leading an existing team through QA/RA endeavors.



Responsibilities

  • Ensure that all products and processes comply with applicable regulatory requirements (e.g., FDA, EU MDR, ISO).
  • Prepare and submit regulatory documentation and applications, including product registrations, certifications, and renewals.
  • Ensure proper documentation of quality incidents, deviations, non-conformances, and corrective actions.
  • Develop and deliver quality-related training programs to employees, ensuring a thorough understanding of quality policies and procedures.
  • Develop, implement, and maintain the company's QMS in compliance with ISO standards and other relevant regulations.


Qualifications


  • 5+ years experience in Quality Engineering supporting the medical device industry.
  • 2+ years in a management capacity with direct reports.
  • In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and other relevant regulations and standards.
  • Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) credentials are a plus.
  • Regulatory Affairs Certification (RAC) or equivalent preferred


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