Regulatory affairs specialist
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 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 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), experience of registration of laboratory equipment is a plus
- Good command of English (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
Read Full Description