Responsible for both Quality Assurance & Regulatory Affair area.
•Ensure that product engineering process (PEP) is strictly followed by project team and all quality requirements are fulfilled. Work closely with project team and provide process supports to project/product team, participate in the review and evaluation on relevant documentation coming from different milestones of project/product development.
•Supervise the change control process is properly followed within design or manufacturing process change, responsible for the change plan approval, document review, and final release the changes within whole product life cycle.
•Provide guidance on license strategy to product development, make product registration plans for new developed products/significant changes, and perform the registration as per plan.
•Catch global regulations and standards updates, ensure they can be implemented in related SOPs and products.
•Analyze the change impact to country license, notify regional units for the changes, perform license update/filing/renewal within whole product life cycle.
•Support oversea product transferred to local manufacturing, including design transfer, R4, NMPA license submission and R5 milestones if necessary.
•Develop and strengthen the relationships with competent authorities, agents, internal departments, as required, to ensure appropriate input into regulatory strategy and gain rapid approval of submissions, and ensure license acquired timely.
•Participate and handle the internal/external audits, initiate and follow-up the continuous improvements.
•Bachelor degree above, major in technical (SW, HW, E&E), project management and/or advance degree is preferred.
•Certificate on ISO13485 and CGMP, QSR820, MDSAP and MDR is a plus.
•More than 4 years experiences in international healthcare, for both project/product development quality assurance and license registration.
• Be familiar with China and international regulations on medical devices in registration and development.
•Experience for medical devices project/product development quality control and external audits
•Good relationship with NMPA, Global license registration experience is preferred.
•Good in written and spoken English and Mandarin.
•Experience in R&D project quality control is a plus.