Regulatory Affairs Specialist in vitro

A foreign company has an open position for Regulatory Affairs Specialist in vitro

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, 2,5 - 3+ years experience in Regulatory Affairs in Medical Devices (manufacturing company or agency)

· Good command of English (intermediate)

· Experience in IVD registration is an advantage, 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 in the center of Moscow