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.
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 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
- Problem solving
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 by clicking here and join the Werfen Team!