Jake Leys
Associate Attorney
O: 651.583.7896
M: 989.763.0149
Jake Leys 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 spanning medical devices, clinical trials, healthcare compliance, data privacy, and transactional work. Jake provides practical, business-focused guidance that helps clients advance business objectives while managing legal and regulatory risk.
Before joining Gardner Law, 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 enables him to translate effectively between technical teams and business leaders and to help clients address compliance challenges with clear judgment, operational awareness, and a strong understanding of the realities behind the legal issues.
Representative Experience
- Advises on clinical and commercial contracting for medical device and digital health programs in the United States and Europe.
- Counsels cross-functional teams on regulatory risk, contract structure, and compliance considerations involving clinical, commercial, marketing, and research activities.
- Supports commercialization efforts through development and negotiation of purchase agreements, pricing structures, and related contracting frameworks.
- Advises on data privacy matters, including HIPAA- and GDPR-related considerations in contracting and operational contexts.
- Brings transactional experience in M&A, IP diligence, and broader due diligence matters for companies in regulated industries.
Education
- Juris Doctor, Boston University School of Law
- Master of Science in Biology / Microbial Ecology, Tennessee Technological University
- Bachelor of Arts, Biology / Microbiology, Chemistry Minor, Northern Michigan University
Bar Admissions and Qualifications
- Michigan
Publications
- Co-author, “Variability in snake skin microbial assemblages across spatial scales and disease states,” ISME Journal (2019)
- Co-author, “Common cutaneous bacteria isolated from snakes inhibit growth of Ophidiomyces ophiodiicola,” EcoHealth (2018)
- Co-author, “Host and geographic range of Snake Fungal Disease in Tennessee, USA,” Herpetological Review (2018)
- Co-author, “Methodological considerations for detection of terrestrial small-body salamander eDNA and implications for biodiversity conservation,” Molecular Ecology Resources (2017)