The Clinical Risk Specialist II will ensure all product complaints are documented, investigated, and reported in compliance with applicable Quality Systems regulations, ISO, FDA, and corporate policies
Job Summary
The Clinical Risk Specialist II will ensure all product complaints are documented, investigated, and reported in compliance with applicable Quality Systems regulations, ISO, FDA, and corporate policies.
BD is a leading global medical technology company focused on advancing health through innovation and collaboration across global teams.
The role offers an environment that supports learning, growth, and becoming your best self while contributing to transforming healthcare.
Matching Summary
The Clinical Risk Specialist II will ensure all product complaints are documented, investigated, and reported in compliance with applicable Quality Systems regulations, ISO, FDA, and corporate policies.
Skills & Requirements
Must-have
MDR/adverse event reporting
Complaint handling software TrackWise
Medical device regulations knowledge
Quality Systems and FDA regulations
Clinical risk assessment
Data analysis for risk reduction
Nice-to-have
Advanced Microsoft Office skills
Excellent verbal and written communication
Ability to interface with regulatory bodies
Presentation skills
Time management and multitasking
Problem solving in limited standardization
Key Requirements
Bachelor’s degree required
3 years clinical experience preferred
3 years medical device industry experience preferred
Experience with complaint handling and MDR reporting