Sanjay Sharma
Head of Regulatory Affairs @ MicroVention-Terumo | RAC Certified
- Role
- Head of Regulatory Affairs for Aneurysm and Peripheral Devices at Microvention-Terumo
- Location
- Trabuco Canyon, CA, US
- LinkedIn followers
- 500 followers
About Sanjay Sharma
Strategic Regulatory Executive with over 20 years of leadership in the medical device industry, consistentlysecuring market access for high-risk, life-saving technologies. Proven track record in orchestrating globalregulatory roadmaps for $500M+ portfolios, including PMA, 510k, IDE, and EU MDR transitions. A decisive leaderskilled in integrating regulatory intelligence with business development to drive portfolio expansion, M&A duediligence, and global compliance for industry giants like Medtronic, MicroVention and Boston Scientific.
Experience
Head of Regulatory Affairs for Aneurysm and Peripheral Devices
Aug 2022 — Present · Aliso Viejo, CA, US
Market Expansion: Spearheaded the regulatory launch of multiple PMA and 510(k) products (e.g.Roadsaver, WEB 17, FREDX, Azur HP18, LVIS EVO), directly contributing to double-digit portfoliogrowth.Strategic Execution: Negotiated complex submissions with the FDA, including IDEs, Q-Subs,510k and PMAs, ensuring zero-interruption to product lifecycles.Enterprise Growth: Serve as a key advisor for Business Development, performing due diligenceon potential acquisitions to ensure regulatory viability and risk mitigation.Talent Transformation: Recruited and build a high-performing RA organization, fostering a cultureof proactive regulatory intelligence and cross-functional excellence
Education
Indian Institute of Technology, Delhi
PhD, Biochemical Engineering
1995 — 2001
Govind Ballabh Pant Engineering College - India
MS, Molecular Biology
1992 — 1995
University of Rajasthan
BS, Life Sciences
1989 — 1992
UC San Diego
Certificate, Regulatory Affairs
2005 — 2005
University of Illinois Urbana-Champaign
Master of Business Administration - MBA, Business Administration and Management, General
2019
Skills
- Regulatory Affairs
- Clinical Trials
- Ide
- Design Control
- Clinical Development
- Regulatory Submissions
- Molecular Biology
- Vaccines
- Validation
- Animal Models
- Iso 13485
- Biochemistry
- Pma
- Medical Devices
- Clinical Research
- Capa
- Fda
- Ind
- R&D
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.