Dhipu Menon
Bangalore
Summary
Highly-motivated employee with desire to take on new challenges. Strong worth ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.Looking forward to understand the changes and ensure a state-of-the-art environment being cohesive to basics and determination.
Overview
11
11
years of professional experience
Work History
Principal Specialist- Regulatory Affairs
Baxter Healthcare
Bangalore, Karnataka
2020.10 - Current
- Global Regulatory Lead for PD systems EM devices
- SME for Regulatory affairs & Compliance related deliverables pertaining to MoH submissions.
- Co-ordination with Respective country RA for Geo-Expansion & sustenance activities from Regulatory perspective.
- Co-ordination for Registration, Renewal, EOL & Geo-Expansion activities.
- RA Lead for NPD,PDLM ,EOL,Strategy Planning & Trainings
Senior Regulatory Affairs Specialist
Stryker Corporation
Gurugam, Haryana
2018.09 - 2020.10
- Assigned under Orthopedic vertical for Regulatory Expertise.
- Regulatory strategist for Sustenance and NPD projects
- Support new product development & communications with Business Divisions.
- Assess policies and emerging issues related to Medical Devices and work closely with divisions to develop and implement strategies to address the impact from regulatory perspective such as EU MDR, ASEAN Regulations, GB/YY for NMPA etc.
- Working with other divisional regulators leads to ensure compliance and standardization across divisions.
Executive
Meril Life Sciences Pvt.Ltd
Vapi, Gujarat
2013.05 - 2018.08
- Product design and development, Product DHF, validation & project management.
- Techno-commercial discussions Brainstorming, co-ordination and documentation for in-vitro performance testing Product approvals (FDA, CE, TGA, PMDA) projects & regulatory documentation
- Major Projects include NPD (High Pressure Balloon Catheter, Aspiration Catheter, PTA Catheter), Pre-Market Readiness For USFDA & EU (Aspiration Catheter, PTCA Catheter), Technical Team for BD and Launch Readiness (Orthopedic Implants & Instruments, LVADs, , Non-Clinical Testing co-ordination (Bench-top testing, FEA & MRI ), Technical Co-ordination for Testing facility Readiness (Plant compliance projects, Testing and test-setup development, Software Validation & Equipment installation & Validation)
Education
BE - Electronics & Communication
Tamil Nadu College of Engineering
Coimbatore, Tamil Nadu2012-05
Pg. Diploma - Industrial Automation
NIELIT (National Institute of Electronics & IT
Calicut,KeralaSkills
- Regulatory Affairs
- Medical Devices
- Endovascular Devices,Orthopedic Device, Renal Care
- Pre-Market Submissions
- CE Marking
- Healthcare
- Non-Clinical Testing
- Product Launch
- Project Management
- Product Lifecycle Management
- Product Submission Support
- Training & Development
- Verification & Validation
- Sustenance support & Variation submissions
- Product Renewals
Timeline
Principal Specialist- Regulatory Affairs
Baxter Healthcare
2020.10 - Current
Senior Regulatory Affairs Specialist
Stryker Corporation
2018.09 - 2020.10
Executive
Meril Life Sciences Pvt.Ltd
2013.05 - 2018.08
BE - Electronics & Communication
Tamil Nadu College of Engineering
Pg. Diploma - Industrial Automation
NIELIT (National Institute of Electronics & IT
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