Sandy Leclair Email & Phone Number
Corporate Compliance Officer @ The Neighborhood Center Inc.
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Sandy Leclair Location
- Mohawk, NY, US
Sandy Leclair Work
- 2025 - now Corporate Compliance Officer @
- 2021 - now RA and QA Consultant @ med-Sherpa
- 2023 - 2025 Director of Regulatory Affairs @
- 2022 - 2023 Sr. Regulatory Affairs Specialist @
- 2020 - 2022 Medical Device and Diagnostic Research @
- 2020 - 2020 Regulatory Affairs Consultant @ LeClair RA
- 2019 - 2020 Regulatory Affairs Consultant @
- 2018 - 2019 Global Regulatory Affairs Project Manager @
- 2018 - 2018 Sr. Technical Writer @
- 2017 - 2017 Regulatory Affairs Project Lead @
- 2017 - 2017 Regulatory Affairs Consultant @
- 2016 - 2017 Staff Regulatory Affairs Specialist @
- 2016 - 2016 Sr. Regulatory Affairs Specialist @
- 2015 - 2016 Sr. Complaint Specialist @
- 2005 - 2015 Regulatory Affairs Specialist @
Sandy Leclair Education
- Northeastern University
Master's Degree (Regulatory Affairs for Drugs, Biologics and Medical Devices)
2015 - RAPS Online University
Medical Device Regulatory Affairs Certificate (Global Regulatory Affairs)
2012 - 2012 - Utica University
BS (Business Administration)
1991 - 1993 - High school
Sandy Leclair Skills
- US Regulations
- EU Regulations
- 510 K
- Complaint Management
- Post Market Surveillance
- MDRs
- FDA
- ISO 13485
- Regulatory Affairs
- Medical Devices
- Quality System
- ISO 14971
- CAPA
- ISO
- Regulatory Submissions
- Validation
- Design Control
- CE marking
- GMP
- Regulatory Requirements
- Quality Control
- Change Control
- Root Cause Analysis
- FMEA
- 21 CFR Part 11
- Quality Auditing
- Quality Assurance
- Biomedical Engineering
- Biocompatibility
- Clinical Trials
- IEC 60601
- Technical Writing
- CQA
- FDA GMP
- Strategy
- Sop
- Technical Files
- Management Review
- Drug Development
- Medical Device Regulatory Affairs Certificate
- Canadian Regulations
- QSR
- Validations
- Quality Systems
- Medical Device Product Development
- Regulatory Strategy
- Clinical Laboratory Management
- Biologics
- MDR Medical Device Regulation
- U.S. Food and Drug Administration (FDA)
- Training
- Regulatory
- Management
- Pmas
- Process Validation
- Document Management
- u.s. Food and Drug Administration Fda
- Integration
- Leadership
- Strategic Planning
- V&V
- Pilgrim
- R&d
- u.s. Food and Drug Administration
Sandy Leclair Summary
- Sandy Leclair, based in Mohawk, NY, US, is currently a Corporate Compliance Officer at The Neighborhood Center Inc.. Sandy Leclair brings experience from previous roles at med-Sherpa, SS White Dental, Inogen and ICON plc. Sandy Leclair holds a Master's Degree in Regulatory Affairs for Drugs, Biologics and Medical Devices @ Northeastern University. With a robust skill set that includes US Regulations, EU Regulations, 510 K, Complaint Management, Post Market Surveillance and more. Sandy Leclair has 3 emails and 1 mobile phone numbers on RocketReach.
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