Senior Project Manager@ DEKRA Product Testing & Certification
Boston, Massachusetts, United States
Harshit Thakkar
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FlashIntel GPTHarshit Thakkar is a highly experienced professional with 17.2 years of work experience in the field of medical devices. He specializes in the European Medical Device Directive (CE Marking), ISO 13485, and Canadian Medical Device Regulations. Harshit has worked as a Senior Project Manager and Regulatory Affairs at DEKRA Product Testing & Certification in Germany, as well as a Regulatory Affairs at Beckman Coulter Diagnostics in the United States. He has also held positions as a Student Supervisor and Biomedical Engineer. Harshit is based in the United States.
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About
Specialties: European Medical Device Directive (CE Marking), ISO 13485, Canadian Medical Device Regulations
Work Experience
Senior Project Manager
Project Manager
Public Safety
Harshit Thakkar's Professional Milestones
- Regulatory Affairs (2008-05-01~2008-08-01): Successfully negotiated and passed regulatory requirements, ensuring compliance and minimizing potential risks.
- Project Manager (2009-02-01~): Successfully executed complex projects, meeting timelines and exceeding client expectations.
Skill
Iso 13485
Medical Devices
Regulatory Affairs
Quality System
Validation
Ce Marking
Biomedical Engineering
Iso 14971
Fda
Capa
Design Control
V&v
Biotechnology
Clinical Trials
Medical Imaging
Quality Assurance
Strategy
Corrective And Preventive Action
Regulatory Strategy
U.s. Food And Drug Administration
Verification And Validation
Certification
Colleagues
Other Named Harshit Thakkar
Frequently asked questions
We found 2 Harshit Thakkar's email addresses
Harshit Thakkar works for DEKRA Product Testing & Certification
Harshit Thakkar's role in DEKRA Product Testing & Certification is Senior Project Manager
Harshit Thakkar works in the industry of Public Safety
Harshit Thakkar's colleagues are Jeffrey Mullins,Maarten Mooij,Nell Van Vuuren
Harshit Thakkar's latest job experience is Senior Project Manager at DEKRA Product Testing & Certification
