Marcelo Antunes Email & Phone Number

Regulatory affairs strategy consultant @ SQR Consulting

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Marcelo Antunes Location

São Paulo, BR

Marcelo Antunes Work

Regulatory affairs strategy consultant @ (June 2007 - Present)
Forum moderator @ (October 2009 - May 2015)
HAS (Harmonised Standards) Consultant for MDR regulation 2017 and 745 @ (October 2021 - Present)
Chairman - ABNT CB 26 - CE 26:130.01 - Brazilian ISO TC 194 mirror @ (February 2017 - Present)
Chairman - ABNT CB 26 - CE 26:150.01 - Brazilian ISO TC 210 mirror @ (February 2009 - October 2021)
Convenor - ABNT CEE 78 Informática em Saúde PG 7 - Dispositivos @ (April 2010 - January 2012)
Secretary - CB 26 committee @ (March 2003 - July 2009)
Professor - Medical Device Regulatory Affairs @ (May 2015 - Present)
Managing Editor @ Revista Medical Devices Brasil (August 2014 - Present)
Senior Faculty Board member @ (July 2012 - Present)
Professor - Medical Device Regulatory Affairs @ (October 2011 - Present)
Expert Member - TC 66 - Safety of Measurement, Control and Laboratory Equipment @ (October 2010 - Present)
Expert Member - TC 62 - Electrical Equipment in Medical Practice @ (January 2008 - October 2021)
Manager - RAPS Brazil Network @ (April 2010 - Present)
Chairman - ABNT CE 03.066.01 - Brazilian mirror to IEC TC 66 (IEC 61010 standards) @ ABNT (April 2011 - October 2021)
Expert member - TC 210 - Quality management and corresponding aspects for medical devices @ (August 2009 - October 2021)
Expert member - TC 215 - Health Informatics @ (April 2010 - October 2014)
MITA Brazilian Representative @ Medical Imaging & Technology Alliance - MITA (January 2013 - December 2015)
IMDRF Software as Medical Device (SaMD) working group member @ IMDRF (May 2013 - September 2015)
Professor - Medical Device Design and Development - Medical Device Regulatory Affairs @ (January 2012 - October 2014)
Blogger @ Blog Dispositivos Médicos (January 2012 - January 2014)
User @ Elsmar Cove (March 2006 - October 2009)
Researcher and Conformity Engineer @ (March 2001 - September 2008)

Marcelo Antunes Education

Universidade Estadual de Campinas
Specialization (Clinical Engineering)
2003-2004
Faculdade de tecnologia de Sorocaba - FATEC
BS (Tecnologia em saúde - Medical devices)
1995-2001

Marcelo Antunes Skills

Medical device risk management
Medical device quality systems
Medical device regulatory affairs
Medical device product development
ISO 13485
Quality Systems
FDA
QSR
ISO 14971
GMP
Risk Management
Medical Devices
Regulatory Affairs
Regulatory Strategy
CAPA
ISO
CE marking
Quality Assurance
Quality Management
Design Control
Product Development
Quality Auditing
Validation
R&D
Auditing
Process Validation
Process Improvement
Regulatory Submissions
Compliance
Testing
Documentation
Biomedical Engineering
510 K
Regulatory Requirements
IEC
Healthcare
Quality Engineering
Root Cause Analysis
ISO standards
Continuous Improvement
Management Review
Computer System Validation
Supplier Audits
Problem Solving
Calibration
Document Management
Software Validation
Technical Writing
Change Control
Supplier Quality
Technology
POS
Regulatory
Strategy
HTML
Medical Imaging
Mita

Marcelo Antunes Summary

Marcelo Antunes, is currently a Regulatory affairs strategy consultant at SQR Consulting. Marcelo Antunes brings experience from previous roles at Elsmar Cove, European Commission and ABNT - Associação Brasileira de Normas Técnicas. Marcelo Antunes holds a 2003 - 2004 Specialization in Clinical Engineering @ Universidade Estadual de Campinas. With a robust skill set that includes Medical device risk management, Medical device quality systems, Medical device regulatory affairs, Medical device product development, ISO 13485 and more. Marcelo Antunes has 6 emails and 8 mobile phone numbers on RocketReach.