Mindray

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