Vijay Damodaran
Associate Vice President and Head, Quality & Regulatory CMC, Medical Devices and Combination Products at Merck
- Role
- Associate Vice President & Head, Quality & Regulatory Cmc, Medical Devices and Combination Products at Merck
- Location
- Indianapolis, IN, US
- LinkedIn followers
- 500 followers
About Vijay Damodaran
QA and Regulatory Leader with extensive experience in Medical Device, Pharmaceutical and Biotech IndustrySpecialties: Medical Devices, Combination Products, Connected Care, SaMD, Contract Manufacturing, Quality Assurance, Quality Control, Quality Systems, Risk Management, Document Controls, CAPA, Change Control, Supplier Quality, Audits, Validation, Design Controls, Quality Agreements, Root Cause Analysis, Lean Six Sigma, Continuous Improvements, Notified Body Audits, Notified Body Opinion (NBOp), EU Regulatory Submissions, Management Review, Management Representative, CE Marking, FDA, cGMP, 21 CFR Part 820, ISO 13485, MDSAP, ISO 14971, EU MDD 93/42/EEC, EU MDR 2017/745, CMDR, JPAL, 21 CFR Part 210/211, 21 CFR Part 4, Medical Device and Combination Product global quality systems and regulations, Quality Compliance
Experience
Associate Vice President & Head, Quality & Regulatory Cmc, Medical Devices and Combination Products
Apr 2023 — Present · Rahway, NJ, US
Skills
- Audit
- Design Validation
- Pen Injectors
- Validation
- Management Review
- Ce Marking
- Risk Management Iso 14971 and Ich Q9
- Regulatory Requirements
- Medical Devices
- Capa
- Notified Body Audits
- Quality Management
- 21 Cfr Part 11
- Supplier Quality
- Microbiology
- Iso 13485
- Design Verification
- Quality System
- Change Control
- Computer System Validation
- Quality Auditing
- Fermentation
- Autoinjectors
- Quality Agreements
- Quality Control
- Prefilled Syringes
- Global Regulatory Compliance
- Gmp
- Drug Delivery
- Lean Six Sigma
- Quality Assurance
- Medical Device
- Design Control
- Fda
- Mdd 93/42/Eec
- Purification
- Gamp
- Contract Manufacturing
- Continuous Improvement
- Combination Products
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