VP Regulatory Compliance US
Keith is responsible for technical consulting, as well as business development and sales. Keith has experience and competence with a large range of devices (Wound care, Vascular, (active) implants, combination devices, IVUS)
The key expertise areas of Keith
- Medical Device Regulatory Affairs (RA) and Quality System expert (Europe, Canada, USA) with 17 years in medical device industry
- Leader capable of building successful teams by critically assessing performance capabilities and developing talent
- Broad medical device industry experience which includes RA, R&D and Quality Engineering functions
- Risk Management (EN ISO 14971:2012) and Clinical Evaluation (MEDDEV 2.7.1) Thought Leader
- Professional Regulatory and Quality System Auditor
Keith was Senior Director or Regulatory Compliance at Accuray (a radiation oncology medical device manufacturer).Keith was also a Senior Project Manager for DEKRA Certification for 9 years. During his time at DEKRA he was a quality system and regulatory lead auditor, as well as a design dossier reviewer. He performed more than 100 audits and 200 Design Dossier/Technical File reviews. Before DEKRA, Keith worked in R&D in various roles as Engineer, Manager and Director, for several technologies including IVUS catheters and super-oxidized water products.
He holds both a First-Class degree and a Ph.D. in Physics from Imperial College of Science, Technology and Medicine, in London.
Learn more about our services within Regulatory Affairs