주요 업무

General Accountability Responsible for ensuring compliance with applicable medical device regulations, guidance, and standards for Class A and B POCT devices. - Assist in regulatory submissions, registrations, and listings globally. Key Responsibilities Regulatory Submissions and Compliance: 1. Prepare and compile country-specific regulatory submissions (e.g., 510(k), CE marking, Canadian medical device licenses). 2. Ensure compliance with FDA, EU, and other international regulations. Documentation and Record Keeping: 1. Maintain and update regulatory files, including IDEs, 510(k)s, and CE dossiers. 2. Manage renewals, device listings, site registrations, and annual reports. Communication and Liaison: 1. Interact with regulatory agencies during submission reviews and audits. 2. Coordinate with cross-functional teams (R&D, Quality, Manufacturing) for project registration. Regulatory Intelligence and Updates: 1. Stay informed about changes in regulatory procedures and climate. 2. Communicate updates to management and relevant teams. Complaint Handling and Reporting: 1. Assess device-related incidents for reporting requirements. 2. Compile and submit reportable events to regulatory authorities. Labeling and Promotional Materials Review: Review product labels and promotional materials for regulatory compliance. Audit Support: Provide regulatory input during external audits to minimize non-compliance findings. Project Management: Manage multiple projects with deadlines, ensuring timely completion. Risk Management: Develop and implement risk assessment processes for marketed devices.

자격 요건

Education: Bachelor’s degree in Engineering, Science, or a related scientific discipline. Experience: Minimum of 2 years in regulatory affairs within a medical device or similar organization. Skills: Strong analytical and problem-solving skills. Excellent written and verbal communication skills. Proficient in MS Office applications and databases. Ability to manage multiple projects and deadlines. RAPS certification is preferred.

우대 사항

Experience in applying and obtaining CE or FDA for medical devices.

선호 비자

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