Taras possesses over 15 years of strategic and tactical regulatory experience with U.S. and international regulatory bodies. He successfully obtained numerous clearances, approvals, and registrations in major world markets (U.S., EU, Canada, Japan, China, Australia, and Brazil), as well as in developing markets (Mexico, Russia, South Korea, Singapore, Taiwan, and Thailand). Taras’ prior leadership of small, medium, and large regulatory teams enables him to work effectively with both nimble startups and mature medical device organizations to achieve their regulatory objectives. Taras is skilled at developing and negotiating preclinical and clinical testing strategies and has an impeccable reputation for delivering timely and high-quality results.
At Veranex, Taras manages clients’ regulatory requirements for product development, manufacturing, submissions, commercialization activities, and postmarket compliance. Taras is responsible for formal and informal communications with the FDA as well as with international regulatory agencies. Taras’ primary functions include:
- U.S. FDA and international regulatory strategies in Europe, Asia Pacific, Latin America, and the Middle East
- Regulatory representative on client companies’ design teams for medical devices and combination products
- Pre-submission packages and client interface for pre-submission meetings
- U.S. FDA regulatory submissions (e.g., 510(k), IDEs, breakthrough designations, PMAs, and HUDs/HDEs)
- Design dossiers and technical files for CE marking, as well as international registrations
- Advertising, labeling, and promotion compliance review and support
- Regulatory representative for audits and inspections
- Support regulatory objectives for significant risk technologies, active implants, capital equipment, and implantables
- Regulatory compliance activities for the FDA’s Quality System Regulation, ISO 13485:2016 requirements, product complaint evaluation, and medical device reporting
Past companies and experience
Taras has successfully authored more than 20 U.S. and international regulatory submissions, including PMAs and 510(k)s. He is skilled at analyzing international regulatory requirements, prioritizing target markets, preparing standardized technical documentation, and communicating with regulators and qualified international agents.
Prior to joining Veranex, Taras served as the global director of Regulatory Affairs at Adhesys Medical, Inc. where he obtained multiple FDA breakthrough device designations and led all U.S. and European regulatory efforts for their Class II and Class III novel polyurethane-based medical adhesives. Prior to this role, Taras held leadership positions at Clinivation, Inc., Genzyme Corporation, and Abiomed. He is a dedicated regulatory professional with expertise in percutaneous catheter based ventricular assist devices (VADs) and associated controllers, hyaluronic acid (HA) based injectables, and biodegradable surgical sealants and topical adhesives. He co-authored an editorial on Global Harmonization in the Regulatory Focus RAPS magazine and routinely lectures on various international regulatory topics.
Taras received his B.S. and M.E. in biomedical engineering from Worcester Polytechnic Institute in Worcester, Massachusetts. He also holds a Regulatory Affairs Certification (RAC U.S.) from the Regulatory Affairs Professional Society (RAPS) and is a Certified Quality Process Analyst (CQPA) by the American Society for Quality (ASQ).