Senior Regulatory Affairs Specialist

Main responsibilities:

• Perform full cycle of registration processes for medical devices as well as changes to the existing dossiers (VIRD, VIRU)
• Documents request from manufactures include working with manufacturers’ databases, share points or other manufacturers’ sources
• Registration dossier preparation (development of local technical files, IFU and other related documentation) for submissions to authorities
• Ensure timely registration of all new products, maintaining existing registered portfolio, tracking validity of dossier documentation and update according to business needs
• Review product dossiers for accuracy and completeness of documentation
• Cooperation with outsourcing companies and cross-functional collaboration
• Local RA and QA Audits attendance
• Maintain and update all applicable databases and trackers
• Dossiers archiving according to the established in the company process
• Review and Approve promo materials
• Participation in conferences and seminars organized by state authorities involving in registration process

Requirements:

• Higher education (Biomedical engineering education / background is an advantage)
• 3+ years of experience in Regulatory Affairs in Medical Devices is required
• Knowledge of English language at least B2 for business communication purposes
• Result-oriented, initiative, proactive
• Team player
• Good communication (collaborative approach) and analytical skills, open-minded

Conditions:

• Competitive salary & annual bonus
• Medical and life insurance
• Meal allowance
• Fitness compensation
• Mobile allowance
• Opportunities for professional development and growth