Pushpita Singh
- Role
- Sr Regulatory Affairs Project Manager at Artivion, Inc.
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
Experience
Sr Regulatory Affairs Project Manager
Apr 2022 — Present
Skills
- Regulatory Analysis
- Complaint Management
- Corrective and Preventive Action (Capa)
- Analytical Chemistry
- Fda
- U.s. Food and Drug Administration (Fda)
- V&V
- 510(K)
- 21 Cfr
- Mdrs
- Supplier Quality
- Hplc
- Complaint Investigations
- Quality Control
- Drug Testing
- Regulatory Affairs
- Regulatory Submissions
- Regulatory Requirements
- Ce Marking
- Internal Audit
- Quality Assurance
- Iso 13485
- Wet Chemistry
- Change Control
- Standard Operating Procedure (Sop)
- Capa
- Medical Devices
- Risk Assessment
- Root Cause Analysis
- Verification and Validation (V&V)
- Gmp
- Quality Auditing
- Technical Files
- Sop
- Good Laboratory Practice (Glp)
- Glp
- Iso 14971
- Pharmaceutical Industry
- Quality System
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