Ivan Whelan Email & Phone Number
Global QA and RA Leader GCE Group @ GCE Group
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Ivan Whelan Location
- United Kingdom
Ivan Whelan Work
- 2022 -now Global QA and RA Leader GCE Group @
- 2021 -2022 Senior QA Audit Consultant @
- 2017 -2021 Managing Director @
- 2020 -2021 Head Of Quality @
- 2014 -2017 Previous Head of 13485 Assessment Delivery Notified Body @ BSI
- 2013 -2014 Consultant QA and RA @
- 2010 -2013 Regulatory Manager @
- 2008 -2010 Business Development Manager @
- 2006 -2008 QA Supervisor @
- 2003 -2006 Quality Assurance Specialist @
- 2000 -2003 QA Analyst @ Norton (IVAX)
Ivan Whelan Education
- BSI Group
Lead Auditor ISO13485 (Medical Devices)
2013-2013 - University of Ulster
Bachelor's degree Hons (Applied Biosciences)
- Queen's University Belfast
Post Graduate (Communications/management)
Ivan Whelan Skills
- Microsoft Office
- Microsoft Excel
- Microsoft Word
- PowerPoint
- Customer Service
- Outlook
- Healthcare
- Hospitals
- Project Management
- Process Improvement
- Change Management
- Medical Devices
- Medical Device Directive
- CE marking
- Regulations
- Quality Assurance
- ISO 14971
- 21 CFR
- Quality Auditing
- Regulatory Affairs
- Software Documentation
- Computer System Validation
- FDA
- Quality System
- Quality System Compliance
- Post Market Surveillance
- Regulatory Documentation
- Management Review
- Global Regulatory Compliance
- Biocompatibility
- Technical Files
- GDP
- ICH guidelines
- Design Control
- FDA GMP
- ISO 13485
- CMDCAS
- Sterilization
- Adverse Event Reporting
- Combination Products
- Regulatory Requirements
- Regulatory Filings
- Regulatory Agencies
- NDA
- Regulatory Guidelines
- Product Complaints
- Complaint Management
- CAPA
- Sop
- Change Control
Ivan Whelan Summary
- Ivan Whelan, based in United Kingdom, is currently a Global QA and RA Leader GCE Group at GCE Group. Ivan Whelan brings experience from previous roles at Trinzo, Meddev Solutions, Terumo Blood and Cell Technologies and BSI. Ivan Whelan holds a 2013 - 2013 Lead Auditor ISO13485 in Medical Devices @ BSI Group. With a robust skill set that includes Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service and more. Ivan Whelan has 2 emails on RocketReach.
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