Senior Regulatory Affairs Specialist, MedTech

2 недель назад

Almaty, Almaty, Казахстан Johnson & Johnson Полный рабочий день

Johnson & Johnson (MedTech division) is looking for a strong candidate for Senior Regulatory Affairs Specialist role based in Almaty, Kazakhstan.


Temporary contract

Main Responsibilities:

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 Requirements: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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