Regulatory Affairs Specialist
Main Responsibilities:
- Perform registration and certification/declaration processes for medical devices
- Documents request from manufactures include working with manufacturers’ databases, share points or other manufacturers’ sources
- Registration dossier preparation
- Ensure timely registration of all new products and obtaining of relevant licenses
- Review product registrations for accuracy and completeness of documentation
- Cooperation with outsourcing companies
- Responsible for accurate documentation of new products for submissions to authorities
- Local RA and QA Audits attendance
- Assessment of the manufacturer's product changes, their impact on local registration dossiers and planning of required actions to ensure business continuity
- Effective cross-functional interaction on issues related to the registration of medical devices and their further circulation on the market
- Maintain and update RD Database: enter new documents to DB and notification of all concerned parties (upon appropriate mailing list)
- Certificates tracking and update in time according business needs
- Dossiers archiving
- Approve: SAP codes, IFU, Advertising materials
- 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)
- 2 + of experience in Regulatory Affairs in Medical Devices preferably
- Knowledge of legislation on registration of medical devices
- Knowledge of English language, sufficient 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