Roberto Cunha Email & Phone Number
Head of Regulatory Affairs and Compliance @ Bloomlife Inc
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Roberto Cunha Location
- Florida, United States
Roberto Cunha Work
- Head of Regulatory Affairs and Compliance @ (November 2020 - Present)
- VP, Quality and Regulatory Affairs @ (July 2019 - June 2020)
- Director Regulatory Affairs and Quality Assurance @ Neurologica (May 2018 - July 2019)
- Director Regulatory Affairs @ (March 2017 - April 2018)
- Senior Manager, Global Regulatory Affairs @ Nipro Diagnostics Inc. (April 2014 - December 2016)
- Manager, Global Regulatory Affairs @ Nipro Diagnostics Inc. (June 2011 - April 2014)
- Director RAQA @ (January 2010 - December 2011)
- Director RAQA @ Anspach Effort (January 2008 - December 2010)
- Director Quality @ (January 2006 - December 2008)
- Director Quality @ Millenium Biologix (January 2001 - December 2006)
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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