Since 2016, Tammy Barnes Carrea has been working in Baebies, Inc 416, 416. Tammy Barnes Carrea is a well-qualified Vice President, Quality Assurance and Regulatory Affairs with over 24 years of work experience. According to Tammy's CV and work profile, this expert has worked at more than nine places with diverse backgrounds and got various skills. Tammy attended school at the Temple University from 2008 to 2014. This person has professional certification in Regulatory Affairs Certified. Tammy can be found in Raleigh, North Carolina – where this expert currently lives. You can search for this person's contacts. We can also provide you with exhaustive contact information upon request.
Name variants:
Tamara Carrea
Last updated Jun 16, 2024
Contact Information
Workplace
Vice President, Quality Assurance and Regulatory Affairs
Durham, NC
Industry
Medical Devices, Mfg Diagnostic Substances
Colleagues
Work History
Vice President, Quality Assurance and Regulatory Affairs
615 Davis Dr SUITE 800, Durham, NC 27713
Advisory committee panel preparation for de novo clearance of SEEKER device. ISO 13485:2016 certification.
from Apr 2016
Vp, Quality and Regulatory Affairs, Bioptigen
Director, Quality and Regulatory Affairs (Leica Microsystems) Responsible for quality and regulatory functions, domestic and international. Cleared EnFocus surgical OCT (Optical Coherence To...
Mar 2015 — Mar 2016
Vice President Regulatory Affairs and Quality Assurance
North Carolina
Single port minimally invasive laparoscopic devices. Robotic surgical devices. Global strategic development and implementation of regulatory and quality solutions for pre-market clearance an...
Feb 2009 — Dec 2014
President and Chief Executive Officer
RegMatters LLC is a boutique regulatory consulting firm specializing in the development and commercialization of new products. The firm is especially suited for start up firms, novel technol...
from Aug 2014
Scientific Advisory Committee Board Member
The Company developed novel materials to be used as bone cements and artificial bone in dental or orthopedic applications.
Jan 2012 — Dec 2012
Vice President Quality, Regulatory Affairs and Clinical Research
Wireless radiation dosimeters for oncology (implantable and ex vivo) VP Regulatory Affairs and Clinical Research 2006-2009 Director Regulatory and Clinical Affairs 2004-2006 Director Regulat...
Oct 2000 — Feb 2009
New Product Development, Design Control Manager, Pharmanetics
1530 Lindbergh Dr, Beaumont, TX 77707
Pharmanetics, Inc. Point of care diagnostic tests and analyzers for coagulation and drug monitoring. Acquired by Helena Laboratories and marketed as the Cascade POC. Design Control Manager 1...
Feb 1996 — Oct 2000
R and D Advanced Manufacturing, Engineer and Supervisor, Amsco Scientific
5960 Heisley Rd, Mentor, OH 44060
Steam, EO and VHP sterilizers, incubators. AMSCO Corporation, now owned by Steris Corporation. Concurrent engineering product development team member to develop new products for technology t...
1992 — 1994
R and D Materials Science Engineer
14000 Technology Dr, Eden Prairie, MN 55344
Electromagnetostrictive linear displacement transducers. Vendor and in house processing and process controls for sensor materials including heat treating, cold working, materials heat/lot an...
1989 — 1992
Education
2008 — 2014
1983 — 1988
Occupations
Executive
Vice President
IT Professional
Software Tester
Director
Doctor
Ophthalmologist
Chief Executive
Computer Specialist
Operations Manager
Physician
Skills
Fda
Medical Devices
Iso 13485
Design Control
Quality System
Product Development
Regulatory Affairs
Commercialization
Quality Control
R&D
Cross Functional Team Leadership
Manufacturing
Biomedical Engineering
Capa
Quality Management
Validation
U.s. Food and Drug Administration
Surgical Instruments
Biotechnology
V&V
Sterilization
Quality Assurance
Surgical Robotics
Clinical Research
Lean Manufacturing
Gmp
Research and Development
Product Launch
Verification and Validation
Corrective and Preventive Action
Medical Sensors
Surgical Devices
Ivd
Regulatory Submissions
Implantable Medical Devices
In Vitro Diagnostics
21 Cfr Part 11
Surgical Technology
Medical Surgical
Leadership
Project Management
Minitab
Change Control
Strategic Planning
Change Management
Program Management