Senior Regulatory Affairs Specialist, MedTech
Johnson & Johnson
- Алматы
- Краткосрочная работа
- Полная занятость
- Perform full cycle of registration processes for medical devices in Kazakhstan, Uzbekistan and Belarus.
- Documents request from manufactures include working with manufacturers’ databases, share points or other manufacturers’ sources
- Registration dossier preparation according to local regulation (Kazakhstan, Uzbekistan, Belarus)
- Ensure timely registration of all new products as well as maintaining LCM of currents portfolio
- Review product registrations for accuracy and completeness of documentation
- Cooperation with outsourcing companies
- Responsible for accurate documentation of new products for submissions to authorities
- Dossiers archiving
- Local RA and QA Audits attendance
- Maintaining of all applicable databases and trackers
- Certificates tracking and update in time according business needs
- Develop relationships: participation in conferences and seminars organized by state authorities involving in registration process
- Higher education (Biomedical engineering education / background is an advantage)
- 3+ of experience in Regulatory Affairs in Medical Devices preferably
- Knowledge of English language, sufficient for business communication purposes
- Result-oriented, initiative, proactive
- Team player
- Good communication skills (collaborative approach), open-minded
- Knowledge of medical device regulation for other CIS countries will be an advantage
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