Base: $61,300.00 – $122,700.00; bonus/equity: not ...
Medical device reporting regulations
Vigilance reports
Complaint handling system
The Regulatory Affairs Specialist II (Medical Events) position supports the Infectious Disease business, responsible for the timely review, documentation, and submission of Medical Device Reports (MDRs) and international vigilance reports
Job Summary
The Regulatory Affairs Specialist II (Medical Events) position supports the Infectious Disease business, responsible for the timely review, documentation, and submission of Medical Device Reports (MDRs) and international vigilance reports.
This role requires interaction with cross-functional teams to gather information for reportability determination and documentation, ensuring compliance with regulations like 21 CFR 803.
Abbott offers a fast-paced work environment with opportunities for training, career development, competitive compensation, and comprehensive health and well-being programs.
Matching Summary
The Regulatory Affairs Specialist II (Medical Events) position supports the Infectious Disease business, responsible for the timely review, documentation, and submission of Medical Device Reports (MDRs) and international vigilance reports.
Salary
Base: $61,300.00 – $122,700.00; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Medical Device Reporting regulations
Vigilance reports
Complaint Handling System
Quality Management System
cross-functional team interaction
Nice-to-have
continuous improvement
professional behavior
leadership in procedures
Key Requirements
BS/BA degree in science or related technical field
4+ years of experience in Regulatory Affairs or Quality
1+ years' experience in IVD or medical device manufacturing