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Jean Simon Location
Boulder, CO, US
Jean Simon Work
2022 -now Executive Director, Regulatory and Clinical Affairs @
2021 -2022 Global Regulatory Affairs Operations Lead @
2019 -2021 Regulatory Operations Director @ Philips Oral Healthcare
2007 -2018 Director of Regulatory Affairs @
2000 -2007 Director RA, CA and Quality Assurance @ Otologics, LLC
1997 -2000 Director, RA @ Bausch & Lomb Surgical
1988 -1997 Regulatory Compliance Manager @
Jean Simon Education
The University of Texas at San Antonio
Jean Simon Skills
Design Control
Regulatory Affairs
GMP
V&V
Clinical Trials
Medical Devices
FDA
Commercialization
CAPA
ISO 13485
CE marking
Quality System
Regulatory Requirements
ISO 14971
21 CFR
R&D
Validation
Biotechnology
Regulatory Submissions
PMA
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 The University of Texas at San Antonio. With a robust skill set that includes Design Control, Regulatory Affairs, GMP, V&V, Clinical Trials and more. Jean Simon has 3 emails and 1 mobile phone numbers on RocketReach.
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