Специалист по регистрации медицинских изделий / Regulatory affairs specialist (In Vitro)

Regulatory affairs specialist In-Vitro Diagnostic

Become part of one of the fastest growing Medical Devices companies globally.

We continue to grow in Russian market and invest a lot in registration process, that's why we are excited to offer you opportunity to join our growing Regulatory Affairs team.

We ready to see onboard a result-oriented and pro-active regulatory affairs professional, with proven in-depth knowledge of IVD medical devices registration.

You will be responsible for a significant part of our business and you will be able to see the impact your work has on the improvement of our healthcare system.

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 (manufacturing company or agency)
• Good command of English (upper - intermediate)
• Experience in running turnkey IVD registration projects. Including document preparation, testing, dossier preparation and submitting.
• 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)
• Full-time job (5/2). We're working 100% in the office.
• Office located near m. Prospekt Mira