Corporate VP Regulatory Affairs
Rick Gaykowski has over 30 years of solid global experience in the medical device, combination product, regenerative medicine, and healthcare industry. During his extensive professional career, Rick has held various executive leadership and transformational management positions in Regulatory/Quality/Clinical, Compliance & Operational disciplines in a broad-range of companies (start-up – Fortune 100). Prior to Xenter, Mr. Gaykowski served as the Vice President of PolarityTE, a biologics regenerative medicine technology company, and the Vice President of Regulatory Affairs for XableCath, Inc, a specialty interventional peripheral device organization. Previously, Mr. Gaykowski served as the Vice President, Global Regulatory Affairs for Acelity/KCI/LifeCell, Inc., a world leader in advanced wound care and negative pressure wound therapy technology, and regenerative medicine tissue products. Prior to Acelity/KCI/LifeCell, Mr. Gaykowski served as Corporate Vice President, Global Regulatory, Quality, Clinical Affairs for Perseon Corporation. Before joining Perseon, Mr. Gaykowski served as Vice President, Global RA/QSystems for Lumenis, Ltd. Earlier to Lumenis, Mr. Gaykowski served as Vice President, Regulatory Affairs for Bard Access Systems, Inc., and previously held positions of Vice President, Regulatory Affairs/Quality Assurance with the Precision Vascular business unit of Boston Scientific; Precision Vascular Systems, Inc., InnerDyne, Inc., Vice President and Director of Regulatory Affairs/Quality Systems with CardioPulmonics, Inc., and Manager of Regulatory Affairs/QA/Clinical Affairs with Symbion, Inc. Mr. Gaykowski holds a Bachelor’s Degree in Behavioral Sciences & Health from the University of Utah.
Mr. Gaykowski’s product experience covers Class I – III, diagnostic & therapeutic product classifications, IDE, 510(k), de novo, PMA, HDE, combination products, 361 HCT/P, 351 biologics products, and Section 513 filings, CE-Marking in accord with MDD 93/42/EEC, ISO 9001/ISO 13485 QMS certification audits, strategic due-diligence assessments for acquisition/merger targets, and direct interaction with leading global regulatory authorities, as well as extensive experience with a variety of international Notified Bodies for QMS integration, transfer, and strategic refinement for CMDCAS and MDR certification and readiness respectively.