Registration and Quality Specialist
Main Responsibilities:
- Provide Quality support in Supplier Management process, assessment of suppliers based on Quality Assurance criteria, company quality policy, standards and local regulations
- Management of product complaints, timely reporting into local system, data trending.
- Handling Customer Complaints
- Perform registration and certification/declaration processes and work independently on each step from initialization till certificates obtained
- Documents Request from manufactures include working with manufacturers’ databases, share points or other manufacturers’ source
- Registration Dossier Preparation
- Review product registrations for accuracy and completeness of documentation is required
- Cooperation with local business
- Cooperation with out sours companies
- Responsible for accurate documentation of new products for submissions to authorities
- Ensure timely registration of all new products and obtaining of relevant licenses
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 insurance
- Mobile allowance
- Opportunities for professional development and growth