RA Specialist

RA Specialist
  • £45,000 per Annum
  • Permanent
  • Ripon, North Yorkshire, England, UK HG4 1NS Ripon North Yorkshire UK HG4 1NS
Job Ref: J2162221
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 07 October 2021
We have an exciting opportunity for a regulatory affairs professional to join a global medical device company based in Ripon.

As a Regulatory Affairs Associate you will be responsible for ensuring all the devices meet the regulatory requirements of the Medical Devices Directive 93/42/EEC as amended by 2007/47/EEC and the Medical Devices Regulation 2027/745 EU. As well as, updating Technical & Master File Documentation to meet new requirements as laid out by MDR and undertaking clinical evaluations in accordance with MEDDEV 2.7/1 rev 4. Some of your key tasks and responsibilities will include:

  • Updating technical file information, with respect to product and process changes, addition of new products and discontinuing products as required.
  • Undertaking product registrations overseas
  • Carrying out clinical research on new products, sourcing clinical articles and web-based information on new products.
  • Analysing clinical data and compiling detailed clinical and regulatory reports.
  • Writing contracts and dealing with suppliers sourcing documentation as required.
  • Working on MDR Remediation activities - completing templates and updating existing information to meet new requirements as specified by the Head of RA.
  • Compiling protocols and reports for PMS / PMSR reports and SSCPs.
  • Analysing data and preparing data and reports as required by the Head of RA.
  • Maintaining standards of quality set by the company as regards attention to detail and accuracy of all work undertaken.

As the ideal candidate you will have a degree in a suitable scientific discipline along with 5 years' experience in the medical device industry, within a regulatory role with exposure to writing/updating of technical files to MDD or MDR. It is essential you have working knowledge of ISO 13485, FDA QSR 820 ISO 14971 and MEDDEV, NBOG and MDCG Guidance's.

06/11/2021 09:00:12
GBP 45000.00 45000.00 Annum

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