Senior International Regulatory Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78fj07

We offer an interesting opportunity to join our Regulatory Affairs team, based in Bussolengo (VR) as Senior International Regulatory Specialist, reporting to the Regulatory Affairs Manager.
This position ensures that global product international regulatory submissions activities are completed in a timely manner so that full compliance with all applicable global regulatory requirements and internal product/project goals is maintained. The person is also to assure availability of Technical Documentation File by preparing and maintain up to date the regulatory Product Application Files applicable for any new or modified Products. (e.g. EU-MDR Technical Documentation File, FDA 510(k))
Responsibilities include collaboration with Quality Engineering and R&D; Departments and other functional areas in the application of all identified regulatory requirements for ensuring Technical Product Documentation File is adequate and accurate for successful regulatory submissions and approvals in each impacted country.
This position must deal with other company departments (mainly Sales)



and international colleagues. Especially Consultants, Subsidiaries, Competent Authorities, Distributors, External laboratories, suppliers colleagues and Third-Party Regulatory agencies (NB, FDA, etc.).
What will your contribution be?
- Program, prepare and maintain up-to-date International product/facility(ies) submissions including international registrations and/or license applications, according to approved Budget Sales.
- Identifies, plans and collects regulatory submission documents for International markets under minimal supervision, in collaboration with Global Company(ies) departments.
- In collaboration with the team verify that all domestic and International Regulatory documents are adequately prepared and collected before the international Product(s) ' Application registrations.
- Provide in timely manner the RA Regulatory Intelligence Specialist (RIS) of any regulatory product registration/

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78fj07