Romuald Urbański

- Responsible for USA, EU and Canada registrations
- Responsible for creation of Regulatory Release Strategies for this projects and regions.
- Responsible to perform submissions and collect all needed technical documentation for EU Certification process and 510 (k) submission documentation for FDA.
- STED and RPS documentation system.
- Support the R&D team on regulatory issues

Regulatory Affairs Manager for Medical Devices in Valeant Sp. z o.o.Sp. J.in EMENA region– Ophthalmic surgical Systems - Bauch & Lomb, Esthetic medical surgery devices – Solta, Viscoelastic ophthalmic surgery solution - Vioser

I introduce you my new company iAuditor. I invite people for cooperation according consultancy medical device business. I focused now for training especially in Europe and Russia
My webpage: www.iauditor.pl
Email: r.urbanski@iauditor.pl
Mobile: +48 730000924

Work in TUV Nord Polska company in position “Lead Aditor of medical devices” (01.12.2004-31.10.2013) 400 companies auditing all on the World (Poland, Brazil, USA, Lithuania, Slovakia, Russia, Bulgaria), Deputy Head of the certification body of Medical Devices(02.01.2010-31.10.2013)