Design Control Engineering
Labelling, UDI and Traceability Specialist
MSc. Engineering Management (DTU)
Available for: Part-time, tasks
- Unique Device Identification (UDI) strategy and implementation.
- Strategy and implementation of Labelling processes.
- Full Traceability for Medical Devices (end to end).
- Implementation of labelling systems (QMS + Technical implementation).
- Regulatory Master Data strategy and implementation.
- Basic UDI-DI strategy and implementation (MDR).
- Project and program Management.
- Implementation of regulatory compliance projects throughout the value chain.
- Complexity Management and mass customization.
- Automation and Robotics in various sectors.
- 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.
Internationally recognized standards:
- MDD 93/42/EC, IVDD 98/79/EC
[Medical Device & In Vitro Diagnostic Directive, and QSR]
- MDR 2017/745 and IVDR2017/746
[Medical Device & In Vitro Diagnostic Regulative]
- FDA regulation
[CFR 21 part 820, part 11]
- GS1 Standards
[GTIN, GLN, GDSN]
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.