Execute the IVDR registration plan according to registration objectives and track progress to ensure completion
Job Summary
Execute the IVDR registration plan according to registration objectives and track progress to ensure completion.
Participate as RA representative in new product development projects, inputting regulatory strategy and ensuring product registration goals are met.
Collect and track national regulations and standards for in vitro diagnostic reagents, organizing internal translation and implementation, and providing training if necessary.
Matching Summary
Execute the IVDR registration plan according to registration objectives and track progress to ensure completion.
Skills & Requirements
Must-have
IVDR registration plan execution
regulatory strategy input
clinical affairs coordination
new product registration submission
regulatory and standard compliance
Nice-to-have
strong analytical and evaluation skills
good judgment and problem-solving
communication and coordination skills
high execution and proactivity
Key Requirements
1+ years of experience in drug or medical device registration
University degree or above
Good English reading, writing, and communication skills