Gardner Law Expands Compliance Group

Gardner Law Expands Compliance Group with Addition of Jake Leys

Gardner Law is pleased to announce that Jake Leys has joined the firm, further strengthening our compliance capabilities. Jake advises companies in the medtech, biotech, pharma and food industries on clinical, commercial, regulatory, privacy, and compliance matters across the product life cycle. He brings in-house and private practice experience that supports clients navigating legal and regulatory risk in highly scrutinized environments.

Jake’s background is particularly valuable for companies managing issues that cross functional lines, including clinical development, commercialization, healthcare compliance, data privacy, and contracting strategy. He provides practical, business-focused guidance that helps clients advance business objectives while managing legal and regulatory risk.

Jake served as corporate counsel at Edwards Lifesciences, where he advised on clinical, commercial, regulatory, privacy, and compliance matters and supported the business through commercialization and acquisition. He also brings private practice experience from Ropes & Gray, where he worked on transactional, regulatory, and litigation matters for companies in highly regulated industries.

With an earlier background in microbiology and pharmaceutical quality assurance, Jake offers clients a practical, well-rounded perspective grounded in both science and law. That combination allows him to help companies address compliance challenges with clear judgment, operational awareness, and a strong understanding of the business realities behind the legal issues.

“Jake brings a practical and multidisciplinary perspective that is highly valuable to clients operating in regulated industries. His in-house experience, private practice training, and scientific background strengthen our ability to help companies navigate compliance challenges with sound legal judgment and business awareness.”
Mark Gardner, Founder & Managing Partner, Gardner Law

View Jake’s full bio on our team page.

Join Jake at Marking 10 Years: Past, Present, and Future Perspectives in FDA Law

We are also pleased to share that Jake will be part of our upcoming May 14 program, Marking 10 Years: Past, Present, and Future Perspectives in FDA Law. 

Jake will join Amanda Johnston and Lisa Damhof for A Decade of Compliance: How Expectations Have Evolved, and What Comes Next, a session focused on how healthcare compliance expectations have changed over the past decade, where enforcement and program design stand today, and what regulated companies should be preparing for next.

The program will be offered both in person in Stillwater and via livestream, with a networking reception to follow for in-person attendees. Across the afternoon, the Gardner Law team will examine the regulatory, compliance, privacy, commercial, and litigation issues that will shape the next decade for companies in FDA-regulated industries.