Tommy Roy RøsholtRegulatory Consultant and Project Manager at Rosholt Consulting
Project Manager and Consultant for various Global Medical Device companies (Q/RA, Regulatory Compliance and Master Data) Working with:
UDI, Basic UDI-DI, labelling, GDSN and EUDAMED Project Manager (Class I-II-III) -- MDR and MDSAP Consultant at Class I manufacturer -- PM for Certificate Transfer Project for Medical Device manufacturer under FDA, MDD (MDR) and MDSAP. Brexit impact analysis, strategy and role out of mitigation plans
Freelance consultant and NPI - PM at WDH/Demant (see areas below)
- NPI Accountable for Oticon Medical releases from 2016 and forward. Development, Production, Logistic and shared service implementation driven through project releases.
- MDSAP Compliance Project Manager, Prepeartion and MDSAP Audit at manufacturing site - Implemented
- FDA UDI Project Manager accountable for William Demant Holdings overall FDA Compliance Project required by the Unique Device Identification Final Rule - Implemented.
- NPI Accountable for major WDH (Oticon) Hearing Aid releases 2013-2015. Managing a range of dedicated project managers and part of the Program Management.
- Development and streamlining of the Design Transfer activities in the NPI function 2013-2017
Dedicated team spirit with an open mind and high ambitions. Enjoys to take a broad and holistic approach to task execution, and simultaneously stays focused on streamlining project, regulatory, business and organizational processes.