Principal @ Red Quill Consultants, LLC (July 2020 - Present)
Senior Manager Regulatory Affairs @ (January 2021 - February 2024)
Regulatory Affairs Director @ (January 2013 - March 2020)
Senior Regulatory Affairs Specialist and Program Manager @ (January 2001 - January 2013)
Director, Quality Assurance and Regulatory Affairs @ (January 1997 - January 2000)
Manager, Regulatory and Clinical Affairs @ (January 1995 - January 1997)
Regulatory and Clinical Affairs Specialist @ (January 1991 - January 1995)
Tamara Daniels Education
Clemson University
Master of Science (M.S.) (Biomedical/Medical Engineering)
1987-1990
Clemson University
Bachelor of Science (BS) (Mechanical Engineering)
1984-1987
Tamara Daniels Skills
21 CFR
Biomedical Engineering
CAPA
CE marking
Clinical Research
Clinical Trials
Cross-functional Team Leadership
Design Control
FDA
ISO 13485
ISO 14971
Medical Device Directive
Medical Devices
Post Market Surveillance
Quality System
Regulatory Affairs
Regulatory Requirements
Regulatory Submissions
U.S. Food and Drug Administration (FDA)
V&V
Verification and Validation (V&V)
Tamara Daniels Summary
Tamara Daniels, based in New York, NY, US, is currently a Senior Manager, Regulatory Affairs at Integra LifeSciences. Tamara Daniels brings experience from previous roles at Red Quill Consultants, LLC, Philips, Defibtech, LLC and Philips Healthcare, formerly Heartstream. Tamara Daniels holds a 1987 - 1990 Master of Science (M.S.) in Biomedical/Medical Engineering @ Clemson University. With a robust skill set that includes 21 CFR, Biomedical Engineering, CAPA, CE marking, Clinical Research and more. Tamara Daniels has 3 emails and 2 mobile phone numbers on RocketReach.
Looking for a different Tamara Daniels?
Find contact details for 700 million professionals.