Regulatory Affairs Specialist - Maternity Leave Milano

Regulatory Affairs Specialist - Maternity Leave
Milano
Lombardia, Milano

For our Clinical Chemistry Strategic Business Unit, based in Milan (Italy), we are looking for a:

**Regulatory Affairs Specialist - Maternity Leave**:

The Regulatory Affairs Specialist handles the Regulatory Affairs activities in the pre-market.

The main accountabilities of the Regulatory Affairs Specialist are:

Support registrations, understand the local requirements and collect the documents and information required by local authorities in EU;

Provide regulatory support on tender requests in EU territories;

Be the reference contact for EU Affiliates and Distributors for Regulatory Affairs issues;

Study and actively monitor the Regulatory requirements in EU;

Give support for product notifications in Repertorio database in Italy;

Participate to associations working groups and activities (Confindustria, Medtech, etc. ).

At least 1 year of experience in the same role, in a Medical Devices or In Vitro Diagnostic Devices Company is preferred.

Knowledge of European Regulation applicable to Medical Devices and/or in Vitro Diagnostic Devices is preferred

Passion for the comprehension of the business.

Good attitude for analysis and synthesis.

Fluent knowledge of English.

**IT skills**: Office, SAP

Organization and time management

Precision and attention to details

Team working

Communication

Problem solving

Flexibility

At Werfen, worldwide leader in the in vitro diagnostics market, consideration and enhancement of people are a key factor for growth and success for the entire company. The possibility of working in an international organization, the quality of interpersonal relationships, the constant attention to people and the possibility to emerge and grow professionally are some of the main elements that characterize our corporate culture. We want people to choose to work in Werfen because they share our same values.

Are you the person we are looking for?

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