Job Summary

• The Clinical Risk Specialist II will perform MDR/adverse event reporting, evaluate clinical use of product, analyze data to reduce occurrence and risk, analyze adverse events and complaint trends, and respond to regulatory inquiries.
• This position ensures that all product complaints are documented, investigated, and reported in compliance with applicable Quality Systems regulations, ISO requirements, FDA regulations, and Corporate, Division, and International policies and procedures.
• At BD, you’ll discover a culture in which you can learn, grow, and thrive, and find satisfaction in doing your part to make the world a better place.

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Skills & Requirements

Key Requirements

• Bachelor’s degree required
• 3 years clinical experience preferred
• 3 years medical device industry experience preferred
• experience in complaint handling and MDR reporting
• knowledge of FDA and international medical device regulations

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