Regulatory Affairs Supervisor

The largest international company has opened a competition for the position of Regulatory Affairs Supervisor

Responsibilities:

Registration Strategy development;
Participation in budget development;
People management (1 employee);
Perform registration and certification/declaration processes for medical devices;
Request documents from the manufactures, dealing with the databases, share points or other sources;
Prepare the dossiers for registration/ re-registration in a timely manner to meet the Workplan;
Ensure timely registration of products and obtaining of the relevant licenses;
Review product registrations for accuracy and completeness of documentation;
Strong cooperation with the outsoursing companies and internal stakeholders;
Local RA and QA Audits attendance;
Maintain and update RD Database: enter new documents to DB and notification of all concerned parties (upon appropriate mailing list);
Certificates tracking and updates in a timely manner according to business needs;
Dossier archiving;
Copy clearance of labelling and promo materials;
Execute trainings in a timely manner;
Develop strong relationship with the key stakeholders;
Participation in official conferences and seminars;
Participating in regular updates/ calls with the GRA and regional RA colleagues;
Change assessment for product’s changes and new regulation impact assessments.

Requirements:

Higher education (Engineering background is a strong advantage);
Relevant experience in RA field within pharma / MD company;
Knowledge of English language Upper-Intermediate (business communication verbal and written);
Communication skills: collaborative approach, open-minded, result-oriented, open for a new experience and strongly dedicated to meet the goals
People management;
Project management skills.

Benefits: