RA Specialist

RA Specialist
  • £45,000 per Annum
    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.

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

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