Anu Singh
- Role
- Senior Principal Regulatory Affairs Specialist at 美敦力
- Location
- Phoenix, AZ, US
- LinkedIn followers
- 500 followers
Manufacturing & ProductionView LinkedIn profile
Experience
Senior Principal Regulatory Affairs Specialist
Mar 2023 — Present
Responsible for performing the coordination and preparation of document packages for regulatory submissions for supplier transfers in collaboration with the newly formed Supplier Optimization team under the Operations Innovation team.
Education
Arizona State University
Master of Business Administration (MBA), Bachelors of Science in Bioengineering, Bioengineering and Biomedical Engineering
Skills
- Regulatory Submissions
- Gcp
- 21 Cfr Part 11
- Fda
- Change Control
- Biomedical Engineering
- Capa
- Regulatory Requirements
- U.s. Food and Drug Administration (Fda)
- Gmp
- Clinical Research
- Design Control
- Regulatory Affairs
- Clinical Trials
- Medical Devices
- Iso 14971
- V&V
- Iso 13485
- Pma
- Quality System
- Ce Marking
- Validation
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