About this role
Role Overview
- 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.
Requirements
- 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