REGULATORY AFFAIRS SPECIALIST

Settore: / Altro /
Azienda: Instrumentation Laboratory spa
Data annuncio: 26/04/2020
Sede di lavoro: Milano
The Regulatory Affairs Specialist handles the Regulatory Affairs activities in the pre-market and in the post-market.

The main accountabilities of the Regulatory Affairs Specialist are:
Manage the Repertorio database in Italy;
Support international registrations out of Europe, in order to understand the local requirements and collect the documents and information required by local authorities;
Accomplish the requests of competent authorities;
Support tender requests in Italy and competent international territories;
Retrieve the products’ documentation with the support of the different Business Units;
Manage Stop Shipments;
Notify Incident Reports in Europe;
Manage Field Safety Corrective actions in Italy and competent international territories, in coordination with the Legal Manufacturer;
Handle CITES permits for products’ import and export;
Support the Company’s International Distribution Center to comply with regulatory customs requests;
Be the reference contact for international Affiliates and Distributors for Regulatory Affairs issues;
Study and monitor the international regulatory requirements in EU, EEMEAI, South East Asia and Latin America;
Partecipate to associations working groups and activities (Confindustria, Medtech, etc.).

The ideal candidate for this position has the following minimum knowledge and experience:
 Master’s Degree in scientific subjects (e.g. Chemistry, Biology, Engineering, Biotechnology, Pharmacy).
 At least 1 year of experience in the same role, in a Medical Devices or In Vitro Diagnostic Devices Company.
 Knowledge of European Directive applicable to Medical Devices and/or in Vitro Diagnostic Devices.
 Passion for the comprehension of the business.
 Good attitude for analysis and synthesis.
 Fluent knowledge of English.
 IT skills: Office, SAP.

 The ideal candidate for this position will exhibit the following skills and competencies:
Organization and time management
Precision and attention to details
Team working
Communication
Problem solving
Flexibility.

We offer a full-time permanent contract. Travels are required up to 10% of working time.

Are you the person we are looking for?

Send us your resume or CV and join the Werfen Team!

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