• QA Responsible and PM for transfer of EC certificates in major life science company
  Validation of software support systems (RIM, Labelling, AMS)
• Timely and successful release of major Class II and Class III Medical Devices
• Prepared and performed successful MDSAP Audits (operations) Class IIa and IIb
• FDA Design Transfer procedures developed and implemented in major Class II company. from zero to successful first FDA inspection
• UDI procedures and system developed and implemented in Class I, II and III life science companies under both FDA and MDR
• Full labelling readiness procedures and labels developed and implemented

Life science and healthcare enthusiast with strong Project Manager experience in the areas of medical devices development, people management, organizational fit to regulatory requirements and regulatory program execution. Strong implementor of projects in larger complex organizations.

Driven by strategic development of the people, business, systems, and organizational processes. Worked with various regulatory project implementations under FDA 21 CFR, MDR/IVDR, MDSAP and ISO13485.