Senior Project Manager, Clinical Evaluation

4 days ago

Santa Clara, California, United States Abbott Laboratories Full time
About the Role

Abbott Laboratories is seeking a highly skilled Senior Project Manager, Clinical Evaluation to join our team in Santa Clara, CA. As a key member of our clinical evaluation team, you will be responsible for providing project management, regulatory strategies, and medical writing expertise to support marketing applications and post-market surveillance filed with China National Medical Products Administration (NMPA).

Key Responsibilities
  • Manage cross-functional teams to ensure seamless collaboration and facilitate bilingual communication in English and Standard Chinese/Mandarin.
  • Acquire and implement expertise in clinical evaluation, up-to-date China NMPA regulations, and pertinent medical and device technology fields.
  • Develop regulatory deliverables, including Clinical Evaluation Reports (CER) and Periodic Risk Evaluation Reports (PRER), with support from external medical writing vendors.
  • Ensure regulatory deliverables are completed on-time and within budget, and engage proactively in drafting responses during China NMPA's review processes.
  • Provide regular project status updates to management teams and contribute to process improvement efforts.
Requirements
  • Bachelor's Degree in a related field or equivalent combination of education and work experience.
  • Minimum 6 years of related work experience with a strong understanding of medical devices, clinical research, or related industry.
  • Solid understanding and application of business concepts, procedures, and practices.
  • Ability to work in a quality system environment and perform tasks that ensure compliance with governmental regulations.
Preferred Qualifications
  • Bachelor's Degree in Life Sciences or advanced degree in biomedical science, medicine, nursing, clinical/mechanical engineering, regulatory affairs, or related fields.
  • Full professional working proficiency in both English and Standard Chinese/Mandarin.
  • Relevant working experience in clinical evaluation, project management, technical/medical/regulatory writing, risk management, biomedical/clinical research, regulatory affairs, or other related experience.
About Abbott Laboratories

Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. We offer a range of benefits, including career development opportunities, free medical coverage, and an excellent retirement savings plan.

Join our team and contribute to the development of innovative medical devices that improve the lives of millions of people around the world.

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