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.