Karen L. Shannon
Medical Device Legal & Regulatory Executive | IVD Commercialization, SaMD, FDA Strategy
- Role
- Corporate Counsel, Diagnostics and Fda Regulatory Strategy at CovarsaDx
- Location
- Naples, FL, US
- LinkedIn followers
- 500 followers
About Karen L. Shannon
Senior life sciences legal executive with deep experience supporting FDA-regulated in vitro diagnostics (IVD) businesses across the full commercialization lifecycle. Extensive background partnering with R&D, quality, regulatory, sales, manufacturing, and supply-chain teams to enable compliant market entry, scale-up, and sustained growth for diagnostics instruments, reagents, consumables, and software-enabled solutions (including SaMD and lab informatics).Recognized for translating complex FDA and global regulatory requirements into practical business strategies that support product development, laboratory partnerships, and commercial execution. Experience spans RUO-to-IVD transitions, U.S. and cross-border launches, lab contracting models, distributor and channel strategies, and diagnostics-specific risk management.PhD-trained scientist and senior in-house counsel within global diagnostics organizations, bringing a pragmatic, business-forward legal approach that accelerates decision-making while protecting innovation and operational integrity.
Experience
Corporate Counsel, Diagnostics and Fda Regulatory Strategy
Nov 2025 — Present · Naples, FL, US
Education
Georgetown Law
JD
1993 — 1997
Caltech
PhD, Chemistry
1989 — 1992
Carnegie Mellon University
Chemistry
1987 — 1989
Houghton University
Bachelor of Science - BS, Chemistry
1983 — 1987
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.