法規經理 (Manager of Regulatory Affairs)

IMTC is seeking a highly motivated Senior Manager of Clinical Regulatory Affairs, who is a team player with solid hands-on experience, and enjoys a fast paced, dynamic work environment. The Senior Manager will be responsible for developing, implementing and advising on global clinical regulatory strategies and ensure successful clinical trials and registrations in line with company business objectives. RESPONSIBILITIES: o Provide strategic regulatory direction and mentorship on programs including the overall regulatory plan, regulatory requirements for clinical studies and marketing approval, development plans and study designs, risk assessments, critical issue management and Health Authority (FDA, TFDA, IRB) interactions. o Ensure the successful implementation and execution of regulatory plans to support product approval and commercialization. o Oversee the preparation and submission of documentation to support investigational and marketing registration packages and ensure timelines are met. o Lead preclinical safety testing project and ensure compliance with all applicable standards for medical electrical equipment and active implantable medical device (IEC 60601-1, IEC 60601-1-2, ISO 14708-3, IEC 62304, IEC 62366, ISO 10993 etc.)