RA Manager

RA Manager
  • £50,000 per Annum
  • Permanent
  • Ripon, North Yorkshire, England, UK Ripon North Yorkshire UK HG4 1NS
Job Ref: J2162240
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 08 October 2021
we have an exciting opportunity for a motivated individual to join a global medical device company based in Ripon as a Regulatory Affairs Manger.

As a Regulatory Affairs Manager, you will be the on-site expert on all regulatory matters. You will be responsible for co-ordinating work undertaken by other specialists, clinical writer (s) and biocompatibility consultants. Some of your key responsibilities and tasks include:

  • Day to day management of a team of technical file writers who share responsibility for all technical files for the site.
  • Creation and maintenance of technical files of all legal manufactured products to MDD requirements
  • Updating Technical files to meet requirements of MDR
  • Creation and maintenance of technical documentation to meet US FDA requirements
  • Creation of RA plans for the design and development teams to support Global markets
  • Assisting and ensuring devices are registered in EU/FDA and UK MHRA databases as appropriate
  • Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance and addressing any issues arising.
  • Support the wider Regulatory Affairs team as required

As the ideal candidate you will have a degree in a relevant scientific discipline and a minimum of 5 years' experience in the medical devices to MDD/MDR. Working knowledge of US FDA requirements and MDSAP are essential. The ideal candidate will be Self-motivated, comfortable with working with people remotely, thus good communication skills, both oral and written. Some flexibility on working hours preferred as the role will involve interaction with US manufacturing sites.

07/11/2021 08:21:11
GBP 50000.00 50000.00 Annum

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