Quality Assurance and Regulatory Compliance Manager

2 weeks ago


Beverly, Massachusetts, United States BioTalent Full time

BioTalent is collaborating with a cutting-edge medical device company specializing in advanced laser and imaging technologies. In this role, you will oversee the production of class III medical devices while guiding a dedicated team through Quality Assurance and Regulatory Affairs initiatives.

Key Responsibilities

  • Ensure compliance of all products and processes with relevant regulatory standards (e.g., FDA, EU MDR, ISO).
  • Prepare and submit necessary regulatory documentation and applications, including product registrations, certifications, and renewals.
  • Maintain accurate documentation of quality incidents, deviations, non-conformances, and corrective actions.
  • Design and implement quality training programs for staff, ensuring comprehensive understanding of quality policies and procedures.
  • Develop, execute, and sustain the company’s Quality Management System (QMS) in alignment with ISO standards and other pertinent regulations.

Required Qualifications

  • Minimum of 5 years of experience in Quality Engineering within the medical device sector.
  • At least 2 years in a managerial role with direct reports.
  • Thorough understanding of ISO 13485, FDA 21 CFR Part 820, and other applicable regulations and standards.
  • Possession of Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) credentials is advantageous.
  • Regulatory Affairs Certification (RAC) or equivalent is preferred.


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