Senior Regulatory Affairs Specialist
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