• Timely and successful Release of major Class II and Class III Medical Devices.
• 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.
• FDA Design Transfer procedures developed and implemented in major Class II company, from zero to successful first FDA inspection.
• Prepared and performed MDSAP Audits (operations) Class IIa and IIb.
• Full MDR GAB analysis performed for various Medical Device companies.
• Transfer of EC certificates in major life science company.

Strong Project Manager with experience in the areas of medical devices development, organizational fit to regulatory requirements and regulatory program execution.

Strong implementor of projects in larger complex organizations. Driven by strategic development of the business and organizational processes.

Worked with various regulatory project implementations under FDA 21 CFR 820, MDD/MDR, MDSAP and ISO13485.