Nick Trilokekar
Regulatory Team Manager at BSI
- Role
- Technical Team Manager at BSI
- Location
- Lafayette, CA, US
- LinkedIn followers
- 500 followers
About Nick Trilokekar
Regulatory and Product Development teams leader with over 15 years of technical…
Experience
Technical Team Manager
Feb 2014 — Present · CA, US
Team leader of technical experts and project managers responsible for CE Marking under the European Medical Device Regulations.Regulatory expert with a Notified Body, with responsibility for managing various aspects of the regulatory process for CE Marking of medical devices.Technical Specialist/Clinical Team Leader conducting conformity assessment of manufacturer technical documentation under MDD & MDR.
Education
Clemson University
Ph.D. Bioengineering
Skills
- R&D
- Medical Devices
- Capa
- Iso 13485
- Pharmaceutical Industry
- Fda
- V&V
- Process Simulation
- Design Control
- Supply Chain Management
- Leadership
- Sourcing
- Vendor Management
- Product Development
- Drug Delivery
- Materials
- Validation
- Biomaterials
- Biotechnology
- Gmp
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