Requirements: English
Company: Medacta Italia
Region: Castel San Pietro , Ticino
The Regulatory Affairs Specialist will work in a team focused on the organisation of the activities related to the registration of Medacta products in the countries in which Medacta is/will be present, ensuring the timely management of all necessary steps to fulfil regulatory requirements and Medacta procedures.
The candidate will be responsible for managing the following activities:
- Review of country-specific regulatory requirements, including existing countries and any new countries;
- Preparation and compilation of regulatory documents;
- Independent management of submissions with local contacts, country by country;
- Close cooperation with research and development, marketing, and clinical studies departments to ensure that requirements are met from the beginning;
- Serving as the contact person for regulatory agencies.
Hard Skills
The resource should also possess the following skills:
- Degree in a technical field (bioengineering, biotechnology, etc.);
- Experience in registration of Medical Devices and familiarity with main regulations (e.g., EU MDR, FDA, TGA);
- Excellent knowledge of English;
- Good knowledge of main computer packages (MS Office, etc.).
Soft Skills
The candidate should demonstrate:
- Methodical approach, accuracy, collaboration, and proactivity;
- Excellent interpersonal skills;
- Ability to identify and respond to complex problems and find solutions;
- Strong focus on achieving objectives.
What We Offer
- Permanent contract;
- Flexible working hours;
- Carpooling organized by Medacta;
- Incentives for mobility by public transport;
- Advantageous conventions;
- Growth opportunities in a continuously improving and expanding environment;
- Annual salary review linked to performance and professional development;
- Continuous training.
Medacta International is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
#J-18808-Ljbffr