Regulatory Affairs & Quality Assurance Manager - Hampshire

Medical Device Class - RA/QA
Ref: 12 Date Posted: Thursday 12 Sep 2019
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Regulatory Affairs & Quality Assurance Manager – Medical Devices

Hampshire

 

Our client is a growing medical device company based in Hampshire, they are looking for a Regulatory Affairs & Quality Assurance Manager to join their team of experts.

 

This is an excellent opportunity or a RA/QA Specialist / Manager to work in a stand-alone within a small team.

 

Our client is a privately owned, established and dynamic business offering a hands-on role with a good level of autonomy.

 

If you have gained good experience within a RA/QA focused position and are ready for a new challenge, please apply today or contact Indo Professionals for more information.

 

Josh@indoprofessionals.co.uk / 01256 597 800

 

Position:

Regulatory Affairs & Quality Assurance Specialist / Manager (non-line)

 

Location:

Hampshire – ideal for a RA/QA Specialist residing in or near the areas of M3, M27, Southampton, Bournemouth, Portsmouth, Salisbury, Eastleigh, Winchester, Basingstoke, Fareham or for someone looking to relocate.

 

Job role:

Within the role, the successful RA/QA Manager will be support CE Marking / UK product registrations, managing and coordinating technical files and the companies QMS. Further responsibilities include;

  • Issuing MDA’s and FSN’s
  • Liaison and coordination with MHRA
  • Non-Conformance reporting
  • CAPA management
  • Managing complaints / product recalls
  • MDD/MDR compliance
  • Managing internal audits

 

Experience required:

The ideal applicant for this dual RA/QA vacancy will have up to date knowledge of MDD/MDR as well as strong experience within quality management. Further experience required includes;

  • Strong experience of CE marking
  • Manufacturing background – ideally
  • Expertise within ISO 13485
  • Internal Audit qualification or experience
  • Strong communication, presentation and influencing skills
  • Able to work in an autonomous and hands-on role

 

Job reference:

J-009

 

 

Indo Professionals is a staffing specialist to the medical device industry. We focus on finding positions within regulatory, quality and clinical research. We work with our job seekers on a project basis, providing one to one consultation and up to the minute market information. Please contact the team today.