For a medical device company with the Italian Affiliate based in Sesto San Giovanni, Milan, we are looking for a Regulatory Affairs Specialist, Southern Europe - EU MDR Implementation.Full time, office-based, temporary assignment for the EU MDR project.
Responsabilità
Review the product technical files to identify aspects that are relevant to the regional organization
Coordinate with global Regulatory Affairs to obtain specific documents/information necessary for product notifications to the Regulatory Authorities in the region
Notify the MDR CE marked medical devices in Italy, Spain, and Portugal
Support the Regulatory Affairs team of the region with the change assessment as per Business Unit requests
Support the local Commercial Organization (e.g. Customer Service, Tender Department, Sales Organization) to answer regulatory queries and ensure that local processes meet regulatory requirements
Functie-eisen
The Ideal Candidate should have:
University degree in Medical Engineering, Physics, or equivalent
2 year of experience in similar position and/or knowledge of MDD and MDR regulations
Ability to work in an international environment
Fluency in English is mandatory
Knowledge of Spanish is desirable.
La ricerca è rivolta ai candidati ambosessi (L.903/77). Ti preghiamo di leggere l'informativa sulla privacy ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).
