Head of Quality and Regulatory Affairs

2 weeks ago

Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter Full time
Job Description

ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter is seeking a highly skilled and motivated Head of Quality and Regulatory Affairs to join their team.

This individual will play a critical role in guiding the organisation's innovative medical products through the regulatory approval process, ensuring compliance with global quality standards.

The ideal candidate will have demonstrable experience with successful regulatory submissions, including FDA, UKCA, and CE marking applications for in vitro diagnostics.

Key Responsibilities
  • Lead Regulatory Strategy: Develop and execute the regulatory strategy for all products across key international markets.
  • Provide Regulatory Guidance: Ensure the team is up-to-date on global regulatory changes and train team members on regulatory requirements.
  • Oversee Submissions: Lead the preparation and submission of regulatory applications, including FDA approvals, UKCA, and CE marking.
  • Post-Market Compliance: Ensure that post-market surveillance activities comply with all regulatory requirements.
  • Manage External Relations: Serve as the key point of contact for communications with regulatory bodies, Notified Bodies, and reimbursement entities.

The Head of Quality will also manage the company's quality systems, including:

  • Achieve ISO13485 Certification: Lead the process to gain and maintain ISO13485 certification, ensuring full compliance with quality standards.
  • Quality Management System (QMS): Oversee the company's QMS, ensuring that all staff are trained on and adhere to quality procedures.
  • Audit Leadership: Lead both internal and external audits to ensure ongoing compliance.

This is an exceptional opportunity to drive the regulatory and quality functions of a company at the forefront of healthcare innovation.

Please note: We are unable to accept applicants who require sponsorship.

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