Текущие вакансии, связанные с Regulatory Affairs Specialist IVD - Russia - Mindray Medical

Regulatory affairs specialist

Responsibilities:

• Managing full cycle of IVD medical devices registration - preparation, submitting and registration dossier for the registration on the market of Russia in accordance with local legislation and standards Interaction with HQ RA regarding collecting registration dossiers and getting information required for registration – regulatory, technical and operational documentation
• Verification of the received regulatory, technical and operational documentation, local test reports regarding compliance with the requirements of Russian legislation.
• Communication with registration agencies & internal stakeholders
• Communication with government institutes & appropriate regulatory authorities
• Supervision of technical and clinical testing, checking laboratories for accreditation/license, evaluating the correctness of test reports.
• Control of actuality of data specified in registration certificates and dossiers. Making changes, if necessary. Keeping up to date with legislative and data updates from the manufacturer and authorized representative.
• Actively participate in teamwork, creating procedures and optimizing interactions with HQ.
• Maintain electronic archives of certificates and dossiers
• Information support in terms of registration issues to marketing, sales and other departments

Requirements:

• Higher education, 3+ years experience in Regulatory Affairs in Medical Devices (producer company or agency)
• Good command of English (upper - intermediate)
• Good knowledge and understanding of local legislation in regulatory sphere
• Result-oriented, pro-active team player, able to work independently, motivated to grow within the company
• Ability to learn lots of new information
• Great analytical and communication skills

Conditions:

• Competitive compensation package including yearly KPI bonus (will be discussed individually during interviews)
• Corporate mobile and equipment support
• Social benefits (Health and Life insurance)

We're working 100% in the office located near m. Prospekt Mira