JOB?RESPONSIBILITES
- Review?the?complaints?of?external?customers?to?improve?quality?policy?and?standard.
- Develop?and?maintain?quality?system,?including?Chinese?Label?and?Manual?Quality?Management,?Product?complaint,?Adverse?Event,?Recall?handling,?internal?quality?audit?and?management,?distributor?interface?with?corporate?QA?management?etc.
- Set?up?registration?plan?based?on?the?business?needs,?ensuring?the?business?compliance?with?national?regulations.
- Familiar?with?CFDA?regulations,?process,?document?review?principle?and?technical?requirements.??Review?registration?dossier?as?internal?examiner?and?guide?the?project?team?members?to?prepare?registration?documents.
- Prepare?regulatory?submissions?and?obtain?regulatory?permits,?including?import/export?clearance?in?a?timely?manner
- Interact?with?and?build?rapport?with?regulatory?agencies?and?notified?bodies?as?required?to?perform?effective?and?fast?track?approval?of?product?registrations.
- Monitor?the?regulation?development?and?regulatory?trend?in?China,?report?the?impact?to?the?company.
- Organize?and?deliver?regulatory?education?and?dissemination?of?regulation?information?to?the?organization.
MINIMUM?REQUIREMENT
1. Bachelor?degree?or?above?in?clinical?laboratory,?health/life?science?discipline?or?the?equivalent?knowledge?and?experience;
2. Solid?knowledge?and?experience?in?RA?of?medical?device?(IVD?preferred),?ISO?knowledge?is?preferred.
3. Minimum?5?years?of?professional?experience?in?a?regulated?environment;?solid?relationship?with?authority?and?office.
4. Rich?experience?in?product?regulatory?submissions?and?successful?registration?track?record;
5. Strong?interpersonal?skills,?sense?of?innovation,?competency?in?coaching,?team?collaboration
6. Fluent?in?English?and?Microsoft?office?skills