Romil Sheth Email & Phone Number
General Manager, Quality Assurance and Regulatory Affairs @ Shalby Advanced Technologies, Inc. (SAT)- Dba. Consensus Orthopedics
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Romil Sheth Location
- India
Romil Sheth Work
- General Manager, Quality Assurance and Regulatory Affairs @ (May 2026 - Present)
- Manager, Regulatory Affairs and Quality Assurance @ (May 2024 - April 2026)
- Manager, Regulatory Affairs @ (August 2021 - April 2024)
- Project Manager, Regulatory Affairs @ (September 2018 - August 2021)
- Senior Specialist, Regulatory Affairs @ (March 2016 - September 2018)
- Specialist, Regulatory Affairs @ (September 2013 - March 2016)
- Associate, Regulatory Affairs @ (July 2011 - September 2013)
Romil Sheth Education
- University of Southern California
M. S (Medical Device & Diagnostics Engineering)
2009-2011 - D.J.Sanghvi College of Engineering
B.E (Biomedical Engineering)
2005-2009
Romil Sheth Skills
- International Registration
- 510(k)
- Change Assessment
- EU Class III Submission
- FDA Q-Sub
- External Alliances
- New Product Development
- Design Control
- Risk Management
- Leadership
- Project Management
- Regulatory Submissions to the Us Fda 510k
- 21 Cfr 820
- Regulatory
- Registration
- Regulatory Affairs
- ISO 14971
- 510k
- Submissions
- Medical Device Regulatory Requirements in Us Class I and Ii
- CE marking
- ISO 13485
- Iia and Iib
- Medical Device Regulatory Requirements in Us
- Medical Device Regulatory Requirements in Eu
- Regulatory Submissions to the Us Fda
- Medical Device Ce Marking
Romil Sheth Summary
- Romil Sheth, based in India, is currently a General Manager, Quality Assurance and Regulatory Affairs at Shalby Advanced Technologies, Inc. (SAT)- Dba. Consensus Orthopedics. Romil Sheth brings experience from previous roles at Shalby Advanced Technologies, Inc. (SAT)- Dba. Consensus Orthopedics and Zimmer Biomet. Romil Sheth holds a 2009 - 2011 M. S in Medical Device & Diagnostics Engineering @ University of Southern California. With a robust skill set that includes International Registration, 510(k), Change Assessment, EU Class III Submission, FDA Q-Sub and more. Romil Sheth has 2 emails and 3 mobile phone numbers on RocketReach.
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