Thirty-three years of experience in the medical device and combination drug/device regulation, manufacturing, quality assurance and R & D arenas. Specialty is working on the pre-meetings and briefings with the FDA.
Titles Held: Corporate Senior Director of RA; Global Director of RA; Director of RA North America; Quality Assurance Manager; Senior Microbiologist
- Has extensive experience in interfacing with the FDA, at the district and headquarters levels, as well as with international regulatory authorities
- Strong international experience including international product registrations, CE mark approvals and import/export activities
- Extensive experience with compliance issues, Warning Letters, product recalls, facility inspections and resulting 483 responses and consent decrees
- Has obtained both PMA’s and 510(k)’s, In-Vitro diagnostics, IND, IDE, PLA and NDA approvals.
- RAC certified with extensive knowledge with combination drugs devices