Sumit Kumar
Transformational & Strategic Regulatory Affairs Leader | Building Scalable RA Functions | Driving Global Compliance, Product Innovation & Market Expansion | Team & Cross-Functional Leadership | Result-Oriented Execution
- Role
- Regulatory Affairs Manager-image Guided Therapy- Devices Business Unit at Philips
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Sumit Kumar
Strategic and results-oriented Regulatory Affairs leader with 18 years of global…
Experience
Regulatory Affairs Manager-image Guided Therapy- Devices Business Unit
Aug 2023 — Present · Pune, IN
Education
Kurukshetra University
B.Tech
2000 — 2004
Manipal Academy of Higher Education
MBA
2004 — 2006
Skills
- Gap Analysis
- Capability Maturity Model Integration (Cmmi)
- Waterfall
- Process Definition
- Software Quality Assurance
- Quality Assurance
- Iso 13485
- Test Planning
- Sdlc
- Iec080000
- System Testing
- Cmmi
- Peer Reviews
- Risk Management
- Team Management
- Agile Methodologies
- Management
- Iso
- Medical Device Directive
- Scrum
- Rohs
- Mdd
- Test Metrics
- Iso 14971
- Software Project Management
- Sepg
- Project Management
- Test Automation
- Software Development Life Cycle (Sdlc)
- Software Development Life Cycle
- Testing
- Iso 9000
- Quality Management
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