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Senior Regulatory Scientist

🏢
Cook Medical
📍 China, China
📍
Location China
📅
Posted June 26, 2026
🚗
Commute Local Area
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Job Description

Overview

The Senior Regulatory Scientist is responsible for conducting thorough reviews of clinical data and literature, developing clinical evaluation and post-market surveillance plans and reports, coordinating regulatory strategies, supporting audits, and fostering culture of compliance and process improvements.

Responsibilities

  • Ensure adherence to COOK values, quality system procedures, policies, and relevant medical device standards and regulations, providing guidance to team members as necessary.
  • Independently conduct reviews of clinical data and pertinent literature for medical devices; develop and/or review clinical evaluation plans and/or reports in alignment with EU, Australian, and Chinese regulatory requirements and industry standards; provide expert clinical input to support premarket reviews, ensuring compliance with applicable regulations.
  • Provide critical scientific review and regulatory-based gui...

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    📍 Location Details

    🌆
    City
    China
    🗺️
    Country
    China
    🚗
    Commute
    Local Area

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