Paula Osorio
Director, Regulatory Compliance Assessments at Johnson & Johnson
- Role
- Director, Regulatory Compliance Assessments at Johnson & Johnson
- Location
- Loveland, OH, US
- LinkedIn followers
- 500 followers
Healthcare & Human ServicesView LinkedIn profile
Experience
Director, Regulatory Compliance Assessments
Jul 2011 — Present · Loveland, OH, US
Education
University of Wisconsin-La Crosse
B.S., Microbiology
1978 — 1982
Adelphi University
M.B.A., Business, International Business
1983 — 1986
Skills
- Iso
- Pharmaceutical Industry
- Sop
- Fda
- Life Sciences
- 21 Cfr
- Iso 13485
- Technology Transfer
- U.s. Food and Drug Administration (Fda)
- Quality System
- V&V
- Quality Control
- Regulatory Requirements
- Gmp
- Regulatory Submissions
- Fda Gmp
- Commercialization
- Microbiology
- Design Control
- Biotechnology
- Ce Marking
- Complaint Management
- Computer System Validation
- Iso 14971
- Validation
- Change Control
- Glp
- Quality Assurance
- Pma
- Medical Devices
- Capa
- Medical Device Directive
- 21 Cfr Part 11
- Quality Management
- Verification and Validation (V&V)
- Iso Standards
- R&D
- Gcp
- Biopharmaceuticals
- Trackwise
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