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18 - 22 October 2021
Virtual EventDelivered in CEST time zone

Tommy Roy Røsholt
Regulatory Consultant and Project Manager at Rosholt Consulting

Profile

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

-----------Implemented Projects------------
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.