2. Lead and implement responsibility to ensure reagent NPI/NPD projects comply with design control procedure and the relevant regulatory requirement.
3. Participate in the projects and follow up the steps in NPI/NPD developing life.
4. Come up the relevant quality input to NPI/NPD core team and mornitor the entire NPI/NPD processes to address URS and quality compliance.
5. Organize NPI/NPD phase review meeting to mitigate product and business risk.
6. Host ECR/ECO review meeting and track ECR/ECO activities to make sure all changes under control.
7 . Organize the preparation for all new product registration audit by CFDA.
2. Has FMEA knowledge and PM experience is preferred.
3. Be familiar with ISO13485:2016 standards and CFDA IVD regulations.
4. Good communication and strong learning capability.
5. English fluent in reading, writing and speaking.
6. Bachelor degree or above on biology, life science, medical related subjects.