Malcolm Pinfold MA, AMIMechE, MTOPRA

Regulatory Affairs Manager, Medical Devices

Malcolm leads the medical devices team at Regulis, where he develops and executes global and European strategies for all device classes, as well as active implantable and in vitro diagnostic devices. Malcolm has been a regulatory and quality systems professional for over 10 years, with a Notified Body, as a consultant and in the medical devices industry.

Value to clients

Malcolm brings a wide range of skills and experience to all client Regulatory Affairs and Quality Systems projects. His scientific and engineering background ensures an appropriate level of robust scientific thinking and knowledge is applied to each and every medical device and to drug/device combination products.

  • Experienced in working with Notified Bodies, Competent Authorities and a wide range of medical device manufacturers
  • An excellent communicator and presenter at all levels
  • Great project management skills and an ability to manage multiple regulatory and quality systems projects for clients of any size.


After completing a First-Class Engineering degree at Cambridge University, Malcolm worked in the packaging, pharmaceutical production, automation and medical device industries before becoming a Scheme Manager, Auditor and Reviewer at the Notified Body, BSI, and subsequently acting as the Medical Device Regulatory Manager for a medium-sized pharma company. Malcolm now manages a growing team of high calibre scientists at Regulis who execute and deliver a wide range of medical device projects.

Other things about Malcolm

Malcolm is a trained ISO 13485 external and internal auditor and is experienced in designing and implementing compliant Quality Systems for manufacturers entering the medical devices industry.

Malcolm has a wealth of experience in Risk Management, Usability Engineering, Medical Device Software and Apps, Biocompatibility and all other aspects of Technical Files/Design Dossiers for CE marking and other global requirements.

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