Regulatory Affairs Specialist
An international company has opened a competition for the position of Regulatory Affairs Specialist
Main Responsibilities:
- Registration dossier as per Eurasian Economic Union preparation;
- Close collaboration with manufacturers to support dossiers preparation;
- Close collaboration with local 3rd parties (such as Consultancy, laboratories, translation agencies);
- Perform registration and certification/declaration processes (if necessary) for medical devices within Eurasian Economic Union (EAEU);
- Documents request from manufactures include working with manufacturers’ databases, share points or other manufacturers’ sources;
- Ensure timely registration of all new products and obtaining of relevant licenses;
- Review product registrations for accuracy and completeness of documentation;
- Cooperation with outsourcing companies;
- Responsible for accurate documentation of new products for submissions to authorities;
- 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 update in time according business needs;
- Dossiers archiving;
- Approve: SAP codes, IFU, Advertising materials;
- Provide trainings: RA, SOP Advertising;
- Develop relationships: participation in conferences and seminars organized by state authorities involving in registration process;
- Change assessment for product’s changes and new regulation impact assessments.
Requirements:
- Higher education (Biomedical engineering education / background is an advantage);
- 2+ of experience in Regulatory Affairs in Medical Devices (EAEU preferably);
- Knowledge of English language, sufficient for business communication purposes;
- Result-oriented, initiative, proactive.