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Senior Project Manager, Clinical Evaluation - China (on-site)
Abbott Laboratories - Santa Clara, CA
posted 2 months ago
About the position
The Senior Project Manager, Clinical Evaluation - China at Abbott is responsible for providing project management, regulatory strategies, and medical writing expertise to support marketing applications and post-market surveillance filed with the China National Medical Products Administration (NMPA). This role involves managing cross-functional teams and authoring regulatory deliverables for various medical device products, ensuring compliance with NMPA regulations and facilitating effective communication in both English and Standard Chinese/Mandarin.
Responsibilities
- Facilitate bilingual communication with cross-functional teams in both English and Standard Chinese/Mandarin.
- Acquire and implement expertise in clinical evaluation and up-to-date China NMPA regulations.
- Strategize and deliberate on clinical data/evaluation-related regulatory strategies with cross-functional teams.
- Communicate with external medical writing vendors on project strategy and timelines.
- Develop regulatory deliverables (CER, PRER, etc.) with support from external medical writing vendors.
- Ensure regulatory deliverables are completed on-time and within budget.
- Engage proactively in drafting responses during China NMPA's review processes.
- Provide regular project status updates to management teams.
- Manage competing and/or shifting priorities.
- Contribute to process improvement efforts.
Requirements
- Bachelor's Degree in related field or equivalent combination of education or work experience.
- Minimum 6 years related work experience with a strong understanding of medical devices or clinical research.
- Solid understanding and application of business concepts, procedures, and practices.
- Experience working in a quality system environment.
Nice-to-haves
- Bachelor's Degree in Life Sciences; Advanced degree(s) in biomedical science, medicine, nursing, or related fields.
- Full professional working proficiency in both English and Standard Chinese/Mandarin.
- Relevant working experience in clinical evaluation, project management, or regulatory affairs.
- Working knowledge of relevant regulations and guidance related to NMPA.
Benefits
- Free medical coverage for employees via the Health Investment Plan (HIP) PPO.
- Excellent retirement savings plan with high employer contribution.
- Tuition reimbursement and student debt program.
- Career development opportunities with an international company.
