Project Manager - Medical field production

Oraș : Sibiu
Departament / industrie : Productie
Tip angajare : Full time
Salariu : Negociabil

We are looking for a Project Manager with experience in medical field production who will be responsible for designing, managing and executing the company’s regulatory strategy, ensuring that the company meets applicable medical device legislation and that company’s products meet all applicable regulatory requirements.
The candidates must have excellent knowledge of the English language and basic French, he/she must be a team player and enthusiastic individual, able to work in a dynamic environment.


The Project Manager shall:

- Propose and execute regulatory approval strategies, including preparation and maintenance of all regulatory submissions.
- Design, draft, and lead regulatory filing submissions to various national/ international competent authorities.
- Lead communication with competent authorities including preparation of technical documentation for pre-submission meetings, submissions, reports and responses to questions and inquiries.
- Perform on a continuous basis the regulatory watch in the applicable jurisdictions and act accordingly to ensure continuous compliance to applicable legislation.