Regulatory Affairs Specialist



This is an excellent opportunity based in Wimbledon working for our client who is a Manufacturer and distributor of capital surgical imaging and theatre integration products, focusing on Endoscopy, Orthopedic Surgery, General Surgery, Surgical Urology, Thoracic, Gynecology, Shock Wave Therapy.


  • Ensuring the declaration of conformity and technical documentation have been drawn up and, where applicable, that the manufacturer has carried out an appropriate conformity assessment procedure
  • Having an available copy of technical documentation, declaration of conformity, and, if applicable, relevant certificates, including any amendments and supplements for inspection
  • Forwarding requests made by the MHRA for samples to the manufacturer
  • Cooperating with the MHRA on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices

About You

  • The ideal candidate will be educated to degree level (or equivalent), preferably in a Science or Engineering discipline, and will bring previous experience of working within Regulatory Affairs in the Medical Device or IVD field
  • A longside this, we are looking for candidates with a strong working knowledge of EU Medical Devices Directives, (90/385/EEC and/or 93/42/EEC and/or 98/79/EC), knowledge and understanding of the EU Medical Devices Regulations, (Regulation (EU) 2017/745 and 2017/746) and experience working within an ISO 13485 certified Quality System
  • Experience of working with regulatory frameworks outside the EU is desirable, but not essential.
  • Good understanding of global regulatory requirements
  • Good knowledge of Quality Managment Systems
  • A minimum of 2-3 years’ experience within the Medical Devices industry.
  • Previous experience within Quality Assurance and/or Regulatory Affairs would be a distinct advantage
  • Good working knowledge of Word and Excel
If you are interested in the above role then please apply or get in touch to discuss further.
Oliver Allen Managed by Oliver Allen
apply Posted - 25.05.2021

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Allowed files: Word, pdf and txt

Consult will endeavour to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.