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Quality & Regulatory Specialist
Remote — US
Support combination-product submissions and maintain the quality system.
What you'll do
- Prepare and maintain regulatory submissions and technical files.
- Manage CAPA, complaint handling and internal audits.
- Advise programme teams on regulatory pathway implications early.
What we look for
- Experience with FDA and Health Canada device or combination-product pathways.
- Strong documentation discipline and attention to detail.