For our Quality and Regulatory Affairs Department, based in Milan (Italy), we are looking for a:
**REGULATORY AFFAIRS SPECIALIST**
The Regulatory Affairs Specialist handles the Regulatory Affairs activities in the pre-market.
The main accountabilities of the Regulatory Affairs Specialist are:
- Support international registrations, understand the local requirements and collect the documents and information required by local authorities;
- Provide regulatory support on tender requests in competent international territories;
- Be the reference contact for international Affiliates and Distributors for Regulatory Affairs issues;
- Work with Company's International Distribution Center to comply with regulatory customs requests;
- Study and actively monitor the International Regulatory requirements in EMEA, South East Asia and Latin America;
- Support the handling of CITES permits for products' import and export;
- 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.
- 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!