Manuel Urena Email & Phone Number
Global Regulatory Strategy Director @ Cochlear
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Manuel Urena Location
- Macquarie Park, NSW, AU
Manuel Urena Work
- 2025 -now Global Regulatory Strategy Director @
- 2020 -2025 Regulatory Affairs Director Asia Pacific @
- 2017 -2020 Senior Director Regulatory Affairs and Quality @
- 2015 -2017 Director Regulatory Affairs @
- 2013 -2015 Senior Regulatory Affairs Manager @
- 2013 -2013 Regulatory Affairs and Quality Assurance Manager - New Product Development @
- 2012 -2013 Regulatory Affairs Manager @
- 2011 -2012 Senior Principal Regulatory Affairs Specialist @
- 2010 -2011 Senior Regulatory Affairs Specialist @
- 2008 -2010 Regulatory Affairs Professional @
- 2006 -2008 Senior Quality Engineer @
- 2002 -2006 Quality and Engineering Manager @ Macam Rubber
- 1996 -2002 Quality Assurance Manager @
- 1995 -1996 Quality Engineer @
Manuel Urena Education
- Tecnológico de Monterrey
MBA (Business)
2000-2002 - Instituto Tecnológico y de Estudios Superiores de Monterrey
Bachelor of Science (BSc) (Mechanical Engineering)
1990-1994
Manuel Urena Skills
- ISO 13485
- Medical Devices
- Regulatory Affairs
- FDA
- Quality System
- CAPA
- ISO 14971
- Design Control
- V&V
- Complaint Management
- Quality Auditing
- Regulatory Submissions
- Regulatory Requirements
- Quality Assurance
- Validation
- GMP
- 21 CFR Part 11
- ISO
- Change Control
- Root Cause Analysis
- See 5+see Less
- Microsoft Excel
- Regulatory
- Project Management
- Engineering
- 21 CFR
- Biomedical Engineering
- Corrective and Preventive Action Capa
- CE marking
- Commercialization
- CQA
- Six Sigma
- Quality Management
- Product Development
- ISO Standards
- R&d
- Sop
- Corrective and Preventive Action
Manuel Urena Summary
- Manuel Urena, based in Macquarie Park, NSW, AU, is currently a Global Regulatory Strategy Director at Cochlear. Manuel Urena brings experience from previous roles at Cochlear and Smith & Nephew. Manuel Urena holds a 2000 - 2002 MBA in Business @ Tecnológico de Monterrey. With a robust skill set that includes ISO 13485, Medical Devices, Regulatory Affairs, FDA, Quality System and more. Manuel Urena has 2 emails and 1 mobile phone numbers on RocketReach.
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