Pooja Dalvi Email & Phone Number
Principal Regulatory Affairs Specialist @ Smith+Nephew
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Pooja Dalvi Location
- Boston, MA, US
Pooja Dalvi Work
- 2021 -now Principal Regulatory Affairs Specialist @
- 2021 -2021 Regulatory Affairs Manager @
- 2019 -2021 Senior Regulatory Affairs Specialist @
- 2017 -2019 Regulatory Affairs Specialist @
- 2015 -2017 Regulatory Affairs Associate @
- 2015 -2015 Clinical Research Coordinator @
- 2015 -2015 Regulatory Affairs Intern @
- 2012 -2012 Medical Device Trainee @
- 2011 -2011 Medical Device Trainee @ All India Institute of Physical Medicine and Rehabilitation
- 2011 -2011 Biomedical Engineering Intern @
Pooja Dalvi Education
- Northeastern University
Master's Degree (Regulatory Affairs for Drugs, Biologics and Medical Devices)
2013-2015 - University of Mumbai
Bachelor's Degree (Biomedical/Medical Engineering)
2009-2013
Pooja Dalvi Skills
- Regulatory Filings
- Medical Device Directive
- Public Speaking
- Quality Assurance
- Quality System Regulation Qsr
- Microsoft Word
- Product Labeling
- Trade Secrets
- Copyrights
- Medical Devices
- Manufacturing
- Adverse Event Reporting
- CE marking
- CLIA
- CMC Regulatory Affairs
- IDE
- Trademarks
- Medical Device Development
- Java
- Matlab
- Bla
- Advanced Microsoft Excel
- IND
- Ich Gcp
- Validation
- PMA
- FDA GMP
- Biomedical Engineering
- Regulatory Guidelines
- FDA
- NDA
- Clinical Trials
- Clinical Development
- Patents
- eCTD
- Management
- Technology Transfer
- Sop
- EU Law
- Labeling
- Intellectual Property
- Regulatory Submissions
- Regulatory Documentation
- HUD
- Quality Control
- Cfr
- Hde
- 510k
- CRO
- C++ Language
- Regulatory Affairs
- GLP
- Word and Powerpoint
- Design Control
- IEC
- Good Laboratory Practice Glp
- GMP
- Good Clinical Practice Gcp
- Health Canada Regulatory Submission
- Regulatory Requirements
- Aami Standards
- U.S. Food And Drug Administration Fda
- Udi And Gtin
- Standard Operating Procedure Sop
- 93/42/Eec Medical Device Directive
- ANSI
- u.s. Food and Drug Administration
- Standard Operating Procedure
- Good Clinical Practice
- Good Laboratory Practice
- Quality System Regulation
Pooja Dalvi Summary
- Pooja Dalvi, based in Boston, MA, US, is currently a Principal Regulatory Affairs Specialist at Smith+Nephew. Pooja Dalvi brings experience from previous roles at ZOLL Medical Corporation. Pooja Dalvi holds a 2013 - 2015 Master's Degree in Regulatory Affairs for Drugs, Biologics and Medical Devices @ Northeastern University. With a robust skill set that includes Regulatory Filings, Medical Device Directive, Public Speaking, Quality Assurance, Quality System Regulation Qsr and more. Pooja Dalvi has 1 emails on RocketReach.
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