Jan Flegeau
- Role
- Associate Director of Regulatory Affairs at Johnson & Johnson MedTech
- Location
- Clearwater, FL, US
- LinkedIn followers
- 500 followers
Healthcare & Human ServicesView LinkedIn profile
About Jan Flegeau
Seasoned regulatory professional with many years of diverse and challenging project…
Experience
Associate Director of Regulatory Affairs
Oct 2018 — Present
Happily supporting the regulatory needs of several divisions of J&J MedTech. Sterilmed (MN) and COHEREX (UT)
Education
Florida International University
Women In Leadership
Northwestern University - Kellogg School of Management
Executive Certificate, Leadership and Management
2011 — 2012
La Sorbonne
International Relations and Affairs
Illinois Wesleyan University
BA, International Business
1986 — 1990
Skills
- Validation
- Collaborative Leadership
- Process Improvement
- Manufacturing
- Iso 14971
- Dmaic
- Commercialization
- Management
- Medical Device Directive
- U.s. Food and Drug Administration (Fda)
- Medical Devices
- Teamwork
- R&D
- Product Development
- Quality Assurance
- Glp
- Regulatory Submissions
- Design Control
- Six Sigma
- Iso 13485
- Healthcare
- Quality System
- Biotechnology
- Orthopedic
- Change Control
- Quality Auditing
- Fda Gmp
- Biomedical Engineering
- V&V
- Leadership
- Gmp
- Regulatory Affairs
- 21 Cfr Part 11
- Complaint Management
- Strategic Alliances
- Product Launch
- Pharmaceutical Industry
- Capital Equipment
- Cross-Functional Team Leadership
- Capa
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