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Director of Quality and Regulatory Affairs

  Billerica,   $170,000 - $190,000

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  Quality    Permanent


Opportunity to lead the site quality and regulatory for a global diagnostics organisation with a diverse portfolio and experienced team! The QARA team are on the cusp of completing a huge achievement and are looking for a seasoned QARA Director in the Medical Device / Diagnostics space to continue the success.

Main Responsibilities

  • Oversee the existing experienced quality & regulatory team through FDA audits and outstanding regulatory compliance queries. 
  • Maintain, drive, and improve the ISO:13485 and 21 CFR 820 compliant systems culture across the organisation
  • Provide operational leadership in planning and management of quality system activities, including:
  • Measurement, analysis and improvement programs, including quality trending
  • Distribution management with respect to country licensure/registration

Experience Required

  • 10+ years' of Quality & Regulatory experience in ISO:13485 & 21 CFR 820 compliant environments
  • Expertise with post market activities; remediation, complaints, product recalls, audit readiness
  • Proven track record of managing a team of quality and/or regulatory professionals
  • Bachelor's in a Life Sciences or equivalent field

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.


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