The role involves executing IVDR registration plans and ensuring registration targets are met in a timely manner
Job Summary
The role involves executing IVDR registration plans and ensuring registration targets are met in a timely manner.
The specialist acts as a regulatory affairs representative in new product development projects, providing regulatory strategy input and following up to ensure product registration goals are achieved.
The position requires coordinating domestic and international clinical matters and assisting with new product registration submissions, renewals, and changes.
Matching Summary
The role involves executing IVDR registration plans and ensuring registration targets are met in a timely manner.
Skills & Requirements
Must-have
IVDR registration management
Regulatory strategy input
Clinical coordination
Product registration submission
Office software proficiency
English reading and writing skills
Nice-to-have
Project management certification
Hospital clinical practice experience
Strong analytical and problem-solving skills
Good communication and coordination
High execution and flexibility
Key Requirements
Over 1 year experience in drug or medical device registration or clinical management
Bachelor's degree or above in medicine, biology, clinical medicine or related fields