Regulatory Affairs Specialist

Описание

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