VP Regulatory Compliance US
Principal Consultant
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)
Before Qserve
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.
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
Learn more about our services within Regulatory Affairs