Lisa Sullivan
Sr. Director, Global Regulatory Affairs, Urology at Boston Scientific
- Role
- Sr Director, Global Regulatory Affairs, Urology at Boston Scientific
- Location
- Marlborough, MA, US
- LinkedIn followers
- 500 followers
About Lisa Sullivan
Results-driven regulatory executive with exceptional leadership experience overseeing a diverse portfolio of medical devices, including IVDs, single-use disposables, implants (absorbable and permanent), capital equipment, laser systems, and imaging technologies.Lead franchise regulatory teams supporting a $2B division, ensuring compliance with global regulations while driving new product development and sustaining initiatives. Adept at navigating complex regulatory landscapes, including EUMDR, FDA premarket notifications (510(k)), De Novo, Class PMAs, presubmissions, panel meetings, and international registrations.Skilled negotiator with global regulatory authorities, including FDA, TGA, Health Canada, Notified Bodies, and Competent Authorities. Extensive audit experience across multiple regulatory agencies.Recipient of Boston Scientific’s 2022 People Leader of the Year – Urology award.
Experience
Sr Director, Global Regulatory Affairs, Urology
Oct 2023 — Present · US
Education
Nichols College
BS, Marketing, Minor: English
1995 — 1999
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