Cure Talent is delighted to partner with a growing Medical Device company based just outside of Glasgow. Due to their continued exceptional growth, we are seeking a QARA Manager to join them.

As the new QARA Manager you will be leading a team of experienced QA & RA professionals, maintaining and developing their QMS, MDR compliance and leading internal & external audits.

The ideal candidate will have a proven background across RA and QA in Medical Devices and a strong understanding of ISO 13485 and MDR (knowledge of GMP is a bonus). You will have experience of managing and developing an ISO 13485 QMS and Batch Release.

Key Responsibilities:

• Management and development of the QMS
• Ensure continued compliance with EUMDR
• Creation and implementation of ISO 13485 compliant SOP’s
• Creation, maintenance and updating of Technical Files
• Support Batch Release of both company own devices and external products

Skills, Experience and Qualifications:

• Proven experience in a Quality Assurance and Regulatory Affairs role in Medical Devices
• Experience of QMS implementation or development
• Experience of Creating, Maintaining or Updating Technical Files
• Proven knowledge and experience of Change Controls, Gap Analysis, CAPA, NCR, Risk Management, PMS, Deviations etc.
• Certified ISO 13485 Internal or Lead Auditor
• Strong knowledge of ISO 13485, ISO 14971, MDD, MDR, FDA, GDP, GMP

If you're looking for an exciting opportunity to be part of a rapidly expanding company at the forefront of health technology innovation, get in touch today!