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
- 2026 -now General Manager, Quality Assurance and Regulatory Affairs @
- 2024 -2026 Manager, Regulatory Affairs and Quality Assurance @
- 2021 -2024 Manager, Regulatory Affairs @
- 2018 -2021 Project Manager, Regulatory Affairs @
- 2016 -2018 Senior Specialist, Regulatory Affairs @
- 2013 -2016 Specialist, Regulatory Affairs @
- 2011 -2013 Associate, Regulatory Affairs @
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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Top Shalby Advanced Technologies, Inc. (SAT)- Dba. Consensus Orthopedics Employees
Garrett Kiesle
President and Chief Operating Officer
El Dorado Hills, CA, US
Rich Szulewski
National Account Director
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Sofia Simeone
Executive Administrative Assistant to CEO
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Gary Ct
Area Vice President
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, MY
Balaji Reguraman
Vice President
Chennai, TN, IN
Satya Manyam
Deputy General Manager
Hyderabad, IN
Deven Siddhpura
Product Development Engineer
Ahmedabad, GJ, IN
Diana McCue
Sr Design Engineer
Lakeville, MA, US
Rohan Thaker
Territory Sales Manager
Vadodara, GJ, IN
Hayden French
Regional Business Director
Littleton, CO, US
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