Regulatory Affairs Manager

My client is looking for a Regulatory Affairs Manager



  • 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

  • alongside 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 Management Systems



  • 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

  • Good command of spoken and written English

  • Attention to detail

  • Variety of work experience a plus



  • 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 by the MHRA

  • Providing the MHRA with all the information and documentation necessary to demonstrate the conformity of a device

  • Forwarding requests made by the MHRA for samples to the manufacturer to ensure that the MHRA has samples or has been given access to the device

  • Cooperating with the MHRA on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices

  • Informing the manufacturer about complaints and reports from health care professionals, patients and users about suspected incidents relating to a device for which they have been designated

  • Terminating legal relationship with the manufacturer if they act contrary to its obligations under these Regulations and inform the MHRA and the relevant notified body of that termination



  • responsible for the design, maintenance and further development of the QM processes



  • ensuring adequate training of employees on the respective QM processes



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