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- Москва
Regulatory Affairs Specialist
An international company has opened a competition for the position of Regulatory Affairs Specialist
Responsibilities:
- Managing full cycle of medical devices registration - preparation, filing and registration dossier for the registration on the market of Russia in accordance with country’s legislation and standards;
- Interaction with HQ RA regarding collecting registration dossiers and getting information required for certification – regulatory, technical and operational documentation;
- Verification of the received regulatory, technical and operational documentation regarding compliance with the requirements of Russian legislation;
- Communication with certification agencies & internal stakeholders;
- Communication with government institutes & appropriate regulatory bodies;
- Control of existing certificates & the expiration dates;
- Maintain electronic archives of certificates and dossiers;
- Information support in terms of registration issues to marketing, sales and other departments.
Requirements:
- Higher education, 2+ years experience in Regulatory Affairs in Medical Devices (producer company or agency);
- Good command of English – intermediate;
- Good knowledge and understanding of local legislation in regulatory sphere;
- Ability to learn lots of new information;
- Great analytical and communication skills.
Benefits:
- Fixed salary (based on interview results);
- Annual bonus;
- Transport compensation;
- Competitive salary and bonus system;
- Medical and life insurance.