Director of Quality and Regulatory (Medical Device)

Michael Page

  • Sunbury, Surrey
  • £80,000 per year
  • Permanent
  • Full-time
  • 16 days ago
  • Apply easily
Lead the Quality and Regulatory strategy for a medical device business, taking ownership of various compliance programmes.
  • Represent role model or servant leader model leadership as a member of senior site management team.
  • Develop and implement the QARA strategy aligned with business goals and regulatory compliance requirements.
  • Collaborate with Engineering, Operations, and Commercial teams to integrate quality and compliance from concept to delivery.
  • Oversee global product registrations and submissions, including CE marking and international approvals for UK products
  • Support in defining regulatory pathways early in product development, including Intended Use and Risk Classification.
  • Ensure compliance with ISO 13485, MDR, FDA 21 CFR Part 820, and other relevant standards.
  • Maintain and enhance the Quality Management System (QMS).
  • Lead internal and supplier audits, investigations, and corrective actions.
  • Analyse QA data to drive continuous improvement and risk mitigation.
Contribute to a therapy area that changes lives Join an excellent team of leaders- Extensive experience in a 13485 setting- Extensive knowledge of MDR and FDA Regulations- Strong leadership track recordOur client is a medical device developer and manufacturer, supplying clinics worldwide- Package TBC

Michael Page