KEY RESPONSIBILITIES 1. China Clinical Pathway for NMPA Registration 61 Lead and responsible for planning the clinical pathway of product registration in China, ensure the implementation &updating of clinical strategy throughout the NMPA approval cycle. 61 Serves as subject matter expert (SME) on China clinical regulations, provide expert clinical regulatory support to the RA team and Medtronic. 2. Clinical Evaluation Report and Global Clinical Evidence Leverage 61 Collaborate with global clinical/medical and cross-functional teams, ensure the CERs (including overseas clinical trial data reports) are fully compliant with the up to date NMPA requirements, Medtronic SOP & WI, and agreed timeline. 61 Review and approve the CER documents on behalf of China RA, communicate with NMPA on the CER deficiency requirements. 61 Prepare clinical evaluation materials including CER or overseas clinical data report per the clinical pathway to support timely NMPA registration. 3. Clinical Trial Regulatory Compliance 61 As China RA representative, review and approve the overseas/in-China clinical trial design & materials for NMPA registration, and the External Research Programs (ERPs) in China. 4. Innovative Pathway 61 Responsible for fully leveraging the innovative pathways (e.g. Green Channel, Prioritize review, etc.) to accelerate the NMPA registration, assess the feasibility and risk of the innovative pathway from clinical value perspective, and responsible for preparing the innovative pathway application dossiers from clinical part. 61 Responsible for apply the special commercial use in Boao, GBA or follow the NMPA policy.
JOB QUALIFICATIONS 61 Thorough knowledge of NMPA medical device regulations, especially clinically relevant regulations/guidance; 61 Demonstrated ability to identify and solve problems independently; 61 Ability to work with a cross-functional team; 61 Effective verbal and written communication skills and presentation skills in both English and Mandarin; 61 Proven record of successful completion of complex tasks.
DESIRABLE 61 Master’s degree in medicine, biostatistics, healthcare, public health, statistic or related area is preferred; 61 3 years or above experience in China clinical pathway planning, China clinical evaluation, and experience in scientific writing is highly preferred; 61 In addition to above, experience in clinical trial design and execution, or education background of statistics is nice to have.
