Winifred Wu

Strategy, regulatory, risk, FDA, mitigation, compliance, lifecycle management, life cycle management, clinical trials, global regulatory submissions, device, combination products, portfolio management, Drug development, strategy, startups

Regulatory & Clinical Strategy, Innovative Products, Policy

Principal, Strategic Regulatory Partners

Winifred Wu is a seasoned executive with over 30 years of experience in medical companies. Ms. Wu founded Strategic Regulatory Partners, LLC in 2011 to bring together an integrated regulatory and clinical advice on innovative product development. Examples of her current and past engagements include due diligence for M&A and joint ventures, opportunity analysis, talent management and coaching, and support of commercial readiness activities. Her clients range from multi-national pharmaceutical and medical devices corporations to private equity investors and start-ups.

In her most recent corporate role, Ms. Wu was a VP of Regulatory and Medical Affairs in the Neuromodulation Sector at Medtronic, responsible for strategic and tactical oversight of 13 therapeutic development programs and several product platforms. During her 16-year tenure as a part of the Neuro sector management team, the organization grew from a venture to $1.6B global business in 2011. Throughout her corporate career, Ms. Wu held positions of increasing responsibility in regulatory, clinical, biostatistics and compliance groups. She served on Portfolio Management Boards, R&D steering Committees, Business Development Council, Clinical Research Boardand Regulatory Talent Management Committee. She led industry working groups at AdvaMed to advance positive regulatory policy changes and also served on nonprofit boards.

Ms. Wu’s technical expertise includes combination products and first-of-a-kind NME and innovative medical technologies. Her record includes a 3-year appointment on an FDA medical device advisory panel, and membership on advisory committees for academic start-up accelerators and patient advocacy groups.

Ms. Wu is a Fellow of Regulatory Affairs Professionals Society. She has received multiple awards from the FDA, Medtronic, and 3M. She holds a B.S.in Pharmacy from the University of Minnesota, an MBA from the University of St. Thomas, and has completed executive training programs at Harvard, Kellogg School of Management, and Tufts Medical School.