Johana Ty

Regulatory Affairs Manager @Hologic, Inc.

Ville de Paris, FR

Management - Management of Manchester site regulatory activites- Multisites meeting planification (Paris, Espoo, Manchester, Liège)- Reporting KPI in Management review to ensure quality compliance and alignment with global strategyIVDR compliance: Key player in transitioning Technical Files- Preparation of all TF parts, from part A to K- Instrument (hardware and software) and Collection containers (7 IVD product references)- EUDAMED database registrations including UDI-DI (+40 IVD products)International submissions: EMEA / US / APAC- US submissions: 510(k) Dossier and pre-submission to FDA- Australia submissions: writing registration and submission of class 1 and Class 3 IVD to TGA- Japan registrations approval for 3 sites - UK CTDA applications and MHRA registrations (40 products)Regulatory support in Quality system compliance- Definition of regulatory strategy and DHF regulatory review for New Product Development Core Teams - Regulatory documentation review, change notification - Integration of regulatory processes to global processes (+100 procedures to review and integrate)- Coordination of software validation (+30 sw validated)

Université Paris-Est Marne-la-Vallée

Licence

Maynooth University

Semestre à l'étranger dans le cadre d'un séjour ERASMUS

ISIFC

Clinical affairs

Université Paris Sud (Paris XI)

Master's degree