Heather Nigro Email & Phone Number
SVP, Regulatory and Quality and Clinical Affairs @ CSA Medical Inc
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Heather Nigro Location
- Woburn, MA, US
Heather Nigro Work
- 2019 -now SVP, Regulatory and Quality and Clinical Affairs @
- 2015 -2019 Vice President, Regulatory and Clinical Affairs @
- 2015 -2015 Senior Director Regulatory Affairs @
- 2013 -2015 Senior Director, Regulatory Affairs, Early Technologies @
- 2011 -2012 Director, Regulatory Affairs @
- 2008 -2011 Senior Manager - Regulatory Affairs @
- 2006 -2008 Associate Director - Regulatory Affairs @ Bristol-Myers Squibb Medical Imaging
- 2005 -2006 Manager - Regulatory Affairs @ Bristol-Myers Squibb, Medical Imaging
- 2000 -2005 Regulatory Affairs Specialist @
- 1997 -1998 Consultant @ ENVIRONMENTAL HEALTH AND ENGINEERING
Heather Nigro Education
- University of Massachusetts Lowell
MS (Industrial Hygiene, Work Environment)
1998-2000 - Massachusetts Maritime Academy
BS (Marine Safety)
1992-1996 - Whitman Hanson Regional High School 1988-1992
Heather Nigro Skills
- FDA
- Regulatory Affairs
- PMA
- Medical Devices
- Regulatory Submissions
- CAPA
- ISO 13485
- Design Control
- Quality System
- GMP
- Pharmaceutical Industry
- 21 CFR Part 11
- Clinical Development
- CE marking
- Clinical Trials
- Biotechnology
- EHS
- Regulatory Requirements
- Quality Assurance
- Sop
- U.S. Food and Drug Administration (FDA)
- Participation
- Sales
- Regulatory Agencies
- Customer Service
- Business Analysis
- Healthcare
- Regulatory
- Regulatory Filings
- u.s. Food and Drug Administration Fda
- Microsoft Word
- Design
- Development
- Strategic Planning
- Hospitals
- Project Management
- Business Development
- Strategy
- Research
- u.s. Food and Drug Administration
Heather Nigro Summary
- Heather Nigro, based in Woburn, MA, US, is currently a SVP, Regulatory and Quality and Clinical Affairs at CSA Medical Inc. Heather Nigro brings experience from previous roles at NxStage Medical, Inc., Covidien (Medtronic Minimally Invasive Therapies Group) and Covidien. Heather Nigro holds a 1998 - 2000 MS in Industrial Hygiene, Work Environment @ University of Massachusetts Lowell. With a robust skill set that includes FDA, Regulatory Affairs, PMA, Medical Devices, Regulatory Submissions and more. Heather Nigro has 2 emails and 2 mobile phone numbers on RocketReach.
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Top CSA Medical Inc Employees
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Mebane, NC, US
Bernie Lane
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Lexington, MA, US
Kris Alvarez
Senior Systems Engineer
Boston, MA, US
Joyce Musacchio
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Acton, Massachusetts, United States
Jody Westerfeld
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Indianapolis, IN, US
Loraine Calderon
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