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
- 3+ years experience in Regulatory Affairs in Medical Devices
- 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
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.