Senior Regulatory Scientist

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.

• → 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 guidance throughout project phases, including directing clinical strategy development, evaluating clinical data, reviewing marketing claims, and conducting claims substantiation, to ensure accuracy, completeness, and suitability for regulatory submission.
• → Oversee post-market surveillance activities, ensuring compliance with regulatory requirements, analyzing findings, and preparing comprehensive plans and reports.
• → Collaborate with cross-functional teams to align clinical evaluation activities with new product development (NPD) initiatives when required.
• →With limited supervision prepare and review clear and comprehensive clinical evaluation and post-market surveillance procedures.
• →Maintain knowledge and disseminate regulatory updates applicable to clinical evaluation and post-market surveillance.
• →Coordinate with Regulatory Affairs Team Lead to develop and execute regulatory strategies for clinical evaluation, while providing support and input for global regulatory submissions.
• →Support internal and external audits related to clinical evaluation and post-market surveillance documentation.
• →Address deficiencies from regulatory bodies when needed.
• →Provide input and review of periodic FDA reports for PMA and investigational devices.
• →Identify and communicate opportunities for process improvement within the regulatory team and foster a collaborative and supportive team environment.
• →Maintain our culture, values and commitment to Ethics and Compliance by recognizing, demonstrating, and enforcing appropriate and compliant behavior.

• Tertiary qualification in either science, engineering, pharmacy or microbiology. A master's degree or higher may be preferred.• 3+ years of documented industry experience in research methodology, information management, regulatory requirements, and medical writing is essential• Experience in regulatory requirements specific to medical devices under the EU MDR, including knowledge of relevant standards and guidelines• Experience effectively and accurately communicating technical medical and scientific information to persons without expertise in the subject area• Intermediate Microsoft Office proficiency (Excel, Word, PowerPoint) essential