regulatory affair specialist a SESTO SAN GIOVANNI

pubblicato
offerta proposta da
tipo di contratto
somministrazione
Candidati ora >

dettagli offerta

pubblicato
luogo di lavoro
sesto san giovanni, lombardia
categoria
Tecnici specializzati, qualità
sottocategoria
Ufficio tecnico
tipo di contratto
somministrazione
riferimento
CX169488
offerta proposta da
CINISELLO BALSAMO

descrizione

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 1 year contract.

 

 

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

competenze

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).

livello di studio

Laurea di primo livello (3 anni)