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Roland Gerard Location
Grez-Doiceau, WAL, BE
Roland Gerard Work
2017 -now Head of compliance @ Obelis Brussels
2016 -2017 Director EMEA Transformation @
1995 -2016 Vice President Regulatory Affairs and Quality Affairs International Division @
1991 -1994 Director Regulatory Affairs - Europe @ Intermedics Inc. (A company of Sulzer Medica)
1988 -1991 Technical Officer @ European Committee for Standardization
Roland Gerard Education
UCL - Catholic University of Louvain La Neuve
Master's degree (Geology/Earth Science, General)
1979-1980
Université catholique de Louvain La Neuve
Master's degree (Geology/Earth Science, General)
1975-1979
Roland Gerard Skills
Regulatory Affairs
Medical Devices
European Union
ISO 13485
CAPA
Regulatory Submissions
Clinical Trials
CE marking
Regulatory Requirements
ISO 14971
Cross-functional Team Leadership
Validation
Product Launch
Own Brand Labeling
Post Market Surveillance
Marketing material review
Notification of the placing on the market
Interaction with notified bodies and Competent Authorities
Field Safety Corrective Actions
Quality System
Leadership
MDS
Regulatory
Registration
Business Development
Process Improvement
Cross Functional Team Leadership
Research
Legislation
FDA
Roland Gerard Summary
Roland Gerard, based in Grez-Doiceau, WAL, BE, is currently a Head of compliance at Obelis Brussels. Roland Gerard brings experience from previous roles at Johnson & Johnson, St. Jude Medical, Inc., Intermedics Inc. (A company of Sulzer Medica) and European Committee for Standardization. Roland Gerard holds a 1979 - 1980 Master's degree in Geology/Earth Science, General @ UCL - Catholic University of Louvain La Neuve. With a robust skill set that includes Regulatory Affairs, Medical Devices, European Union, ISO 13485, CAPA and more.
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