Technical Quality Manager

A unique opportunity for a highly capable individual to oversee and manage all operational & quality assurance aspects of the products in the UK.

The company is a UK virtual legal manufacturer (ISO13485 – NB BSI) who owns two substance based low risk medical devices and a cosmetic product. You will work closely with supply chain/logistics and external consultants who currently manage the ISO13485 QMS, technical file and EU Representative.

You must have experience at senior level with a hands-on approach of Regulatory Affairs Quality and Technical within the Medical Device industry working with class I/IIa and Is substance medical devices ideally.

 

Responsibilities

 

  • Day-to-day management of the regulatory and quality assurance components of the fictitious Legal Manufacturer entity (Medical Device).
  • Running a fully integrated third-party contract manufacturing business in Northwest England (all products are made and released)
  • Cross-functional Assistance:
  • An Italian-based group technical team. Full technical, regulatory, and QA support
  • Manager of Supply Chain and Logistics (UK)
  • Outside consultants and contractors hired to oversee the current ISO13485 QMS,
  • Technical Files (MDD, UKCA, MDR), Responsible Person (Cosmetic), and EU Representative; Senior Management Representative and company point of contact with Notified and Approved Bodies; Management UK Representative and company point of contact with MHRA.

 

 

Requirements

  • Minimum 7 years of hands-on experience managing third-party contract contracting and distribution businesses using an established and mature ISO13485 Quality Management System in a quality assurance operation capacity within the medical device industry
  • EUDAMED and Art.120(3) and EU Importers knowledge would be a notable benefit. Minimum of five years of experience in regulatory matters.
  • Working with substance-based devices (including post fill gamma sterilisation) would be highly useful but is not a must. Direct experience with class I/IIa & I(s) medical device(s) is required.
  • Prove you have the skills, self-assurance, and experience to run a business. Audits for Notified Body surveillance and recertification (significant support from Group Technical Team)
  • Degree level of education (strong preference for a scientific or engineering degree)
  • The skills and background necessary to take on the position of Person Responsible for Regulatory Compliance within the Company.
  • An essential requirement is to show that you have a can-do, hands-on, and entrepreneurial mindset.

 

 

If you have the skills and experience for this opportunity and the ambition to take on this position, please call Eleri Morgan on 01273 059767 for further details or email your CV today to Eleri.morgan@hayburysearch.com

 

Eleri is a Client Partner at Haybury Search covering Europe, UK, North America and Asia.

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