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
- Global QA and RA Leader GCE Group @ (March 2022 - Present)
- Senior QA Audit Consultant @ (July 2021 - March 2022)
- Managing Director @ (June 2017 - August 2021)
- Head Of Quality @ (April 2020 - March 2021)
- Previous Head of 13485 Assessment Delivery Notified Body @ BSI (January 2014 - May 2017)
- Consultant QA and RA @ (July 2013 - January 2014)
- Regulatory Manager @ (March 2010 - August 2013)
- Business Development Manager @ (March 2008 - March 2010)
- QA Supervisor @ (February 2006 - March 2008)
- Quality Assurance Specialist @ (April 2003 - February 2006)
- QA Analyst @ Norton (IVAX) (February 2000 - April 2003)
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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