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...