Head of Quality and Regulatory Affairs Specialist

3 weeks ago

Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd - Science, Technology, Engineering and Manufacturing Recruiter Full time
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 include: Lead Regulatory Strategy:
  • Develop and execute the regulatory strategy for all products across key international markets.
  • Ensure the team is up-to-date on global regulatory changes and train team members on regulatory requirements.
Provide Regulatory Guidance:
  • Ensure that post-market surveillance activities comply with all regulatory requirements.
  • Serve as the key point of contact for communications with regulatory bodies, Notified Bodies, and reimbursement entities.
Oversee Submissions:
  • Lead the preparation and submission of regulatory applications, including FDA approvals, UKCA, and CE marking.
Post-Market Compliance:
  • Manage the company's quality systems, including achieving ISO13485 certification and ensuring full compliance with quality standards.
  • Oversee the company's Quality Management System (QMS), ensuring that all staff are trained on and adhere to quality procedures.
This is an exceptional opportunity to drive the regulatory and quality functions of a company at the forefront of healthcare innovation. Ideal candidates will be passionate about bringing life-changing products to market while ensuring the highest regulatory and quality standards.

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