Greg Calder Email & Phone Number
Senior Director | Regulatory Project Management and Operations @ Fresenius Medical Care
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Greg Calder Location
- Norwell, MA, US
Greg Calder Work
- 2023 -now Senior Director | Regulatory Project Management and Operations @
- 2016 -2023 Director, Regulatory Affairs Devices @
- 2014 -2016 Manager Regulatory Affairs @
- 2013 -2014 Principal Regulatory Affairs Associate @
- 2011 -2013 Manager, Regulatory Affairs @
- 2008 -2011 Regulatory Affairs Specialist @
- 1994 -2008 Sr. Software and Systems Test Engineer @
- 1984 -1994 Multiple @
Greg Calder Education
- Northeastern University
None (Technical Writing; Software Engineering)
1988-1996 - Blue Hills Technical Institute
ASET (Electrical Engineering Technology)
1982-1984 - Foxboro High School 1977-1981
Greg Calder Skills
- Design Control
- Medical Devices
- Biotechnology
- Regulatory Affairs
- FDA
- Commercialization
- CAPA
- GMP
- Quality System
- R&D
- Product Launch
- Validation
- Systems Engineering
- Quality Assurance
- ISO 13485
- Hardware Diagnostics
- ISO 14971
- Quality Control
- CE marking
- Continuous Improvement
- Clinical Trials
- V&V
- 21 CFR
- Regulatory Requirements
- Biomedical Engineering
- Regulatory Submissions
- FDA GMP
- 21 CFR Part 11
- Quality Auditing
- Product Development
- Sop
- Design of Experiments
- ISO
- Medical Device Directive
- GLP
- Supplier Quality
- FMEA
- Quality Management
- Root Cause Analysis
- Cross-functional Team Leadership
- IEC 60601
- SPC
- Business Analysis
- Decision-Making
- Leadership
- Management
- Research and Development (R&D)
- ISO Standards
- U.S. Food and Drug Administration (FDA)
- Verification and Validation (V&V)
- Hospitals
- Strategic Planning
- Project Management
- Cross Functional Team Leadership
- Decision Making
- Sales
- Program Management
- Regulatory
- Healthcare
- Verification and Validation V&V
- Research and Development R&d
- u.s. Food and Drug Administration Fda
- u.s. Food and Drug Administration
- Research and Development
- Verification and Validation
Greg Calder Summary
- Greg Calder, based in Norwell, MA, US, is currently a Senior Director | Regulatory Project Management and Operations at Fresenius Medical Care North America. Greg Calder brings experience from previous roles at Fresenius Medical Care North America and Haemonetics. Greg Calder holds a 1988 - 1996 None in Technical Writing; Software Engineering @ Northeastern University. With a robust skill set that includes Design Control, Medical Devices, Biotechnology, Regulatory Affairs, FDA and more. Greg Calder has 4 emails and 2 mobile phone numbers on RocketReach.
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