Global Regulatory Affairs Operations Lead @ (February 2021 - September 2022)
Regulatory Operations Director @ Philips Oral Healthcare (August 2019 - February 2021)
Director of Regulatory Affairs @ Covidien (Medtronic Minimally Invasive Therapies Group) (January 2007 - January 2018)
Director RA, CA and Quality Assurance @ Otologics, LLC (January 2000 - January 2007)
Director, RA @ Bausch & Lomb Surgical (January 1997 - January 2000)
Regulatory Compliance Manager @ (January 1988 - January 1997)
Jean Simon Education
The University of Texas at San Antonio
Masters of Science (Organic Chemistry)
Jean Simon Skills
21 CFR
Biotechnology
CAPA
CE marking
Clinical Trials
Commercialization
Corrective and Preventive Action (CAPA)
Design Control
FDA
GMP
ISO 13485
ISO 14971
Medical Device Directive
Medical Devices
PMA
Quality System
R&D
Regulatory Affairs
Regulatory Requirements
Regulatory Submissions
Research and Development (R&D)
V&V
Validation
Verification and Validation (V&V)
Patient Monitoring
Management
Regulatory
Customer Service
Leadership
Jean Simon Summary
Jean Simon, based in Boulder, CO, US, is currently a Executive Director, Regulatory and Clinical Affairs at Sientra, Inc.. Jean Simon brings experience from previous roles at Invitae, Philips Oral Healthcare, Covidien (Medtronic Minimally Invasive Therapies Group) and Otologics, LLC. Jean Simon holds a Masters of Science in Organic Chemistry @ The University of Texas at San Antonio. With a robust skill set that includes 21 CFR, Biotechnology, CAPA, CE marking, Clinical Trials and more. Jean Simon has 3 emails and 7 mobile phone numbers on RocketReach.
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