John is a seasoned Regulatory Affairs Professional focusing primarily on project management and regulatory compliance within the Medical Device and Bio-Tech Industries. Hehas professional experience in Medical Device Regulatory Affairs, Connected Healthcare, Artificial Intelligence, and a vested interest in business development.
In recent years, John has been working with global start-up companies with breakthrough technologies with the aim to bring revolutionary healthcare solutions into the global market.
John’s core expertise is bringing products from new product development to global market transfer and commercial release. He also excels at formulating strategies for regulatory submissions and in creating multidisciplinary teams to resolve regulatory hindrances. He works to ensure the strategic planning and preparation of FDA Pre-Submissions, Breakthrough Device Designation, IDEs, 510(k)’s, De Novo’s, PMA’s, CE Marking and international registrations. He also resolves regulatory concerns that arise via deficiency letters, product complaints, adverse events, recalls and oversee remediation activities to maintain regulatory compliance.
John has extensive professional experience working in various therapeutic areas including Dental Implants, Ophthalmology, Radiology, Cardiology, Endoscopic Technologies, Neurosurgery, Gynecology, Endo-surgery, Renal Therapies, and Diagnostic Devices. John has worked with small startups to fortune 100 companies including, DePuy Synthes, Ethicon, Fresenius Medical Care.
John has held leadership roles as the Director and Head of Regulatory Affairs within the industry as well as teaching roles in the academia. John was a university professor and director of the graduate Drug Regulatory Affairs program where he has taught candidates in the Masters, Pharm.D. and Ph.D programs Medical Device Regulatory Affairs.
Fun Fact: John enjoys hiking, biking, and spending time with his two munchkins – Christian and Christina – and the rest of the minion crew.