Clinical Evaluation Project Lead, Medical Device Specialist
3 days ago
Welcome to Abbott Laboratories, a global healthcare leader that drives innovation and improves lives worldwide. 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 are seeking a highly skilled Clinical Evaluation Project Lead to join our team in Santa Clara, CA. As a key member of our Clinical Evaluation team, you will provide project management, regulatory strategies, and medical writing expertise to support marketing applications and post-market surveillance filed with China National Medical Products Administration (NMPA).
The estimated salary for this position is $83,600.00 - $167,200.00 per year, depending on location and qualifications. Benefits at Abbott include career development opportunities, free medical coverage for employees, an excellent retirement savings plan, tuition reimbursement, and more.
In this role, you will be responsible for:
- Facilitating bilingual communication with cross-functional teams in both English and Standard Chinese/Mandarin to ensure seamless collaboration.
- Acquiring and implementing expertise in clinical evaluation, up-to-date China NMPA regulations, NMPA guidance, China national or medical standards, and pertinent medical and device technology fields.
- Strategizing and deliberating on clinical data/evaluation-related regulatory strategies with cross-functional teams.
- Communicating with external medical writing vendors on project strategy, timelines, and addressing any arising challenges effectively.
To succeed in this role, you will need:
- A Bachelor's Degree in a related field OR an equivalent combination of education or work experience.
- Minimum 6 years related work experience with a strong understanding of specified functional area (medical devices, clinical research experience, or related industry).
- Solid understanding and application of business concepts, procedures, and practices.
Preferred qualifications include:
- Bachelor's Degree in Life Sciences; Advanced degree(s) 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 experience, risk management, biomedical/clinical research, regulatory affairs, clinical/quality/R&D engineering, or other related experience.
Apply now to take the first step towards a rewarding career with Abbott Laboratories. We are committed to employee diversity and offer a dynamic work environment that fosters growth and development.
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