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Regulatory Affairs Officer

J422461 Tyne And Wear North East £26K - £30K / Year

Do you have regulatory experience in the Medical sector or are looking to launch an exciting career as a regulatory professional? If so this could be a great opportunity to consider! One of our long standing UK device manufacturers is looking for a regulatory affairs officer to join their established team following a promotion. This role is Monday to friday and office based in the North East of England....potential candidates must meet this requirement to be considered.

To cover and maintain the QA/RA system in accordance with the latest relevant standards for the product ranges produced. Assist in registration of devices with worldwide regulatory bodies and collate the necessary information.

You will join an existing team of 4 regulatory professionals, supporting them across the full range of hospital device products.

Key Duties

  • Comprehensive understanding of regulatory requirements applicable to the company
  • Working knowledge of ISO 13485, UK Medical Device Regulations 2002, Regulation (EU) 2017/745 (MDR)
  • Ensure technical documentation is maintained and reviewed regularly against all regulatory standards
  • Ensure Declarations of Conformity up kept up to date
  • Maintain all information on the MHRA website
  • Liaise with the Quality department on aspects of quality related documentation where required
  • Work alongside New Product Development in the process of incorporating new products into the business, ensuring all relevant documentation is available and stored in the correct areas
  • Update any relevant databases as assigned eg: EUDAMED
  • Ensure naming conventions are consistent throughout all documentation
  • Cover for other areas in the department when required - eg: Registrations
  • Any other tasks that are deemed necessary to fulfil the job role to the satisfaction of the company objectives

Package and Benefits

  • Up to £30k starting salary
  • Flexitime with 2 days in credit or 1 day deficit is allowable.
  • Pension, Perkbox and wider company benefits

Key Skills and Qualifications

Candidates must have:

  • Working knowledge of Global Medical Device Regulations
  • Strong attention to detail
  • Effective cross-functional communication and cooperation
  • Desire to learn and focus on continued professional development
  • Be a positive influence on team morale


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