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Steve Linhares Location
Taunton, MA, US
Steve Linhares Work
2019 -now Vice President Clinical Affairs, Regulatory Affairs and Quality Assurance at Morphic Medical @
2019 -now Vice President Clinical and Regulatory Affairs and Quality Assurance @
2017 -2019 President @ SJL Compliance Consulting, Inc
2010 -2017 Vice President of Regulatory, Clinical and Quality @ NeoGraft Technologies, Inc.
2008 -2010 Director of Regulatory, Quality and Clinical Affairs @
2008 -2008 Consultant @
2005 -2008 Director, Clinical Sciences @
2000 -2005 Director ASP Services @
1981 -1999 Vice President: R and D and Clinical @
1979 -1981 Research Associate @
Steve Linhares Education
Bridgewater State University
BS (Physics)
1976-1979
Coyle and Cassidy Memorial High School
Diploma
1971-1975
coyle cassidy 1971-1975
Saint Anthony Taunton 1963-1971
Steve Linhares Skills
Medical Devices
FDA
ISO 13485
CAPA
Clinical Trials
21 CFR Part 11
Quality System
Regulatory Affairs
Validation
Clinical Research
Design Control
R&D
Biomedical Engineering
Lifesciences
Hardware Diagnostics
Oncology
DMAIC
Computer System Validation
Biotechnology
Quality Assurance
Sop
ISO
Regulatory Submissions
Root Cause Analysis
Clinical Data Management
Quality Control
GCP
Quality Auditing
ISO 14971
CRO
Minitab
Pharmaceutical Industry
V&V
SPC
Product Launch
GMP
CTMS
Process Simulation
Commercialization
Regulatory Requirements
Design of Experiments
Technology Transfer
FMEA
Biopharmaceuticals
GxP
Clinical Development
GLP
Change Control
Sales
Healthcare
Customer Service
Project Management
Microsoft Excel
Microsoft Word
Business Development
Research
Strategic Planning
Steve Linhares Summary
Steve Linhares, based in Taunton, MA, US, is currently a Vice President Clinical Affairs, Regulatory Affairs and Quality Assurance at Morphic Medical at Morphic Medical, Inc. Steve Linhares brings experience from previous roles at GI Dynamics, SJL Compliance Consulting, Inc, NeoGraft Technologies, Inc. and Insulet Corporation. Steve Linhares holds a 1976 - 1979 BS in Physics @ Bridgewater State University. With a robust skill set that includes Medical Devices, FDA, ISO 13485, CAPA, Clinical Trials and more. Steve Linhares has 2 emails and 1 mobile phone numbers on RocketReach.
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