Director of Regulatory & Quality Affairs: ex-C. R. Bard
- 20+ years of experience in Regulatory and Quality Management in the medical device industry; Handled worldwide regulatory aspects for the company, including PMA submission, 510k applications, clinical trials, CE mark activities, etc.; M. Ed.

Senior Research Assistant: ex-PRA International
- 15+ years of clinical research experience, including supervisory, clinical site management (Phase II-IV); Ensured that best practices for study conduct were leveraged across the clinical organization and implemented process efficiencies where possible; BS in Zoology

Regulatory Affairs Manager: ex-Boston Scientific
- Over 10 years of diverse experience in bioabsorbable implants, electrical devices and cardiovascular implants; Accomplished in preparing 510k, IDE, Shonin and Design Dossier submissions and interfacing directly with the FDA;  BS in Biology

Senior Clinical Research Associate: ex-GlaxoSmithKline
- 10+ years of experience in implementing and monitoring clinical trials; Adept at performing study initiation activities, interim monitoring visits and study closure; BS in Mechanical Engineering

Regulatory Affairs & Quality Assurance Consultant: ex-LifeScan
- 20+ years of experience in the biotechnology industry, including monoclonal antibodies, recombinant proteins, biopharmaceuticals, medical devices and diagnostic products; Superb knowledge of BLA, IND, IDE and 510 (k) filings, ISO 9000 and QSR; Ph. D.