Resumes
Resumes
Director, Regulatory Affairs Devices At Fresenius Medical Care North America
View pageLocation:
4 Edwards Ave, Damariscotta, ME
Industry:
Medical Devices
Work:
Fresenius Medical Care
Director, Regulatory Affairs Devices at Fresenius Medical Care North America
Fresenius Medical Care May 2014 - Jan 2016
Manager Regulatory Affairs
Fresenius Medical Care Apr 2013 - May 2014
Principal Regulatory Affairs Associate
Haemonetics Jun 2011 - Mar 2013
Manager, Regulatory Affairs
Haemonetics Oct 2008 - Jun 2011
Regulatory Affairs Specialist
Director, Regulatory Affairs Devices at Fresenius Medical Care North America
Fresenius Medical Care May 2014 - Jan 2016
Manager Regulatory Affairs
Fresenius Medical Care Apr 2013 - May 2014
Principal Regulatory Affairs Associate
Haemonetics Jun 2011 - Mar 2013
Manager, Regulatory Affairs
Haemonetics Oct 2008 - Jun 2011
Regulatory Affairs Specialist
Education:
Northeastern University 1988 - 1996
Blue Hills Technical Institute 1982 - 1984
Foxboro High School 1976 - 1981
Blue Hills Technical Institute 1982 - 1984
Foxboro High School 1976 - 1981
Skills:
Fda
Medical Devices
Capa
Regulatory Affairs
Iso 13485
R&D
Design Control
Quality System
Validation
Product Development
Iso 14971
V&V
Gmp
Cross Functional Team Leadership
Clinical Trials
Quality Control
Regulatory Submissions
Quality Assurance
Regulatory Requirements
Product Launch
Biomedical Engineering
Iso
Biotechnology
Ce Marking
Quality Management
Commercialization
Hardware Diagnostics
Continuous Improvement
Fda Gmp
21 Cfr Part 11
Quality Auditing
Design of Experiments
Medical Device Directive
Glp
Supplier Quality
Root Cause Analysis
U.s. Food and Drug Administration
Systems Engineering
21 Cfr
Sop
Fmea
Iec 60601
Spc
Research and Development
Iso Standards
Verification and Validation
Business Analysis
Decision Making
Leadership
Management
Medical Devices
Capa
Regulatory Affairs
Iso 13485
R&D
Design Control
Quality System
Validation
Product Development
Iso 14971
V&V
Gmp
Cross Functional Team Leadership
Clinical Trials
Quality Control
Regulatory Submissions
Quality Assurance
Regulatory Requirements
Product Launch
Biomedical Engineering
Iso
Biotechnology
Ce Marking
Quality Management
Commercialization
Hardware Diagnostics
Continuous Improvement
Fda Gmp
21 Cfr Part 11
Quality Auditing
Design of Experiments
Medical Device Directive
Glp
Supplier Quality
Root Cause Analysis
U.s. Food and Drug Administration
Systems Engineering
21 Cfr
Sop
Fmea
Iec 60601
Spc
Research and Development
Iso Standards
Verification and Validation
Business Analysis
Decision Making
Leadership
Management
Certifications:
Critical Thinking
Linkedin
Greg Calder
View pageGreg Calder
View pageLocation:
United States