Head of Regulatory Affairs and Compliance @ Bloomlife Inc
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Roberto Cunha Location
Florida, United States
Roberto Cunha Work
2020 -now Head of Regulatory Affairs and Compliance @
2019 -2020 VP, Quality and Regulatory Affairs @
2018 -2019 Director Regulatory Affairs and Quality Assurance @ Neurologica
2017 -2018 Director Regulatory Affairs @
2014 -2016 Senior Manager, Global Regulatory Affairs @ Nipro Diagnostics Inc.
2011 -2014 Manager, Global Regulatory Affairs @ Nipro Diagnostics Inc.
2010 -2011 Director RAQA @
2008 -2010 Director RAQA @ Anspach Effort
2006 -2008 Director Quality @
2001 -2006 Director Quality @ Millenium Biologix
Roberto Cunha Education
Universidade Federal de Pernambuco
Bachelor of Science (B.S.) (Chemical Engineering)
1990-1995
UFPE
BSc (Chemical Engineering)
1990-1995
Roberto Cunha Skills
Lean Manufacturing
Clinical Trials
Hardware Diagnostics
IEC 60601
Quality Assurance
Biomedical Engineering
FMEA
R&d
ISO 13485
QSR
Biotechnology
Pharmaceutical Industry
Diagnostics
Public Speaking
PMA
Commercialization
CE marking
Regulatory Affairs
Computer System Validation
Regulatory Requirements
Quality Management
Root Cause Analysis
510 K
Customer Service
Continuous Improvement
Cross Functional Team Leadership
u.s. Food and Drug Administration Fda
Process Simulation
Quality Auditing
FDA
Quality System
ISO
CQA
Validation
Technology Transfer
ISO 14971
21 CFR Part 11
Medical Devices
CAPA
Research and Development R&d
Regulatory Submissions
Manufacturing
Design Control
Regulations
21 CFR
Change Control
Quality Control
GMP
Leadership
Management
V&V
Product Development
Corrective and Preventive Action Capa
Research and Development
u.s. Food and Drug Administration
Corrective and Preventive Action
Roberto Cunha Summary
Roberto Cunha, based in Florida, United States, is currently a Head of Regulatory Affairs and Compliance at Bloomlife Inc. Roberto Cunha brings experience from previous roles at Defibtech, LLC, Neurologica, MOTUS GI Medical Technologies Ltd. and Nipro Diagnostics Inc.. Roberto Cunha holds a 1990 - 1995 Bachelor of Science (B.S.) in Chemical Engineering @ Universidade Federal de Pernambuco. With a robust skill set that includes Lean Manufacturing, Clinical Trials, Hardware Diagnostics, IEC 60601, Quality Assurance and more. Roberto Cunha has 3 emails and 1 mobile phone numbers on RocketReach.
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