Speakers
The US Regulatory Framework for Combination Products
Jerzy Wojcik has more than 26 years of experience guiding medical device and drug–device combination product programs through global development, clinical readiness, regulatory approval, and lifecycle management. He is recognized for translating complex global regulatory and quality requirements into executable development and commercialization strategies that support product approval and sustained compliance.
Throughout his career, Jerzy has led global regulatory strategy and quality system implementation across diverse markets. He has directed and authored complex device regulatory submissions, including 510(k), PMA, EUA, and IDE applications, as well as EU Technical Files. In addition, he has overseen and prepared eCTD-format drug submissions for IND, BLA, NDA, and MAA applications, ensuring compliance with applicable regulatory requirements and agency expectations. He has supported high-risk and novel technologies ranging from implantable devices to combination products and biologics.
Prior to EdgeOne Medical, he held global regulatory leadership roles at Baxter Healthcare and Avery Dennison, and earlier in his career he worked in regulatory risk consulting at Deloitte. Jerzy also provides regulatory and quality due diligence for venture capital firms and innovation hubs evaluating early- and growth-stage medical technology companies. He has served as a retained expert witness in U.S. federal court proceedings involving medical device development activities.