Москва
Олимпийский проспект 16с5
Олимпийский проспект 16с5
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