Abbott is seeking a Principal Regulatory Affairs Specialist for its Diabetes Care Division, based in Alameda, CA. The role focuses on ensuring timely product registration and compliance for the Asia Pacific market, requiring expertise in regulatory submissions for medical devices and strong cross-functional collaboration
Job Summary
This role leads strategic planning to ensure timely regulatory registration and release of diabetes care products into the Asia Pacific market.
The position offers access to free medical coverage, a high employer contribution retirement plan, and tuition reimbursement benefits.
Candidates will act as a liaison between cross-functional teams including Quality, R&D, and Commercial to resolve complex regulatory challenges.
Matching Summary
Match Score: 85
Abbott is seeking a Principal Regulatory Affairs Specialist for its Diabetes Care Division, based in Alameda, CA. The role focuses on ensuring timely product registration and compliance for the Asia Pacific market, requiring expertise in regulatory submissions for medical devices and strong cross-functional collaboration.
Salary
Base: $100,000.00 – $200,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings, tuition reimbursement
Skills & Requirements
Must-have
Bachelor's Degree in Scientific discipline
Experience with 21 CFR 820 and ISO 13485
Strategic planning for product registration
Nice-to-have
Fluency in Chinese is highly desirable
RAC certification from Regulatory Affairs Professionals Society