Product Reviewer IVD for Physiological Markers

Job Description Apply now Product Reviewer IVD for Physiological Markers At TÜV SÜD Group we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark. We take the future into our hands. We are TÜV SÜD Group. Your Tasks Perform Technical Documentation Assessments (TDA) for in vitro diagnostic medical devices in accordance with applicable IVDR requirements and internal notified body procedures Support assessments of Korean and international manufacturers seeking certification under the IVDR and related conformity assessment procedures Responsible for the review the Performance evaluation (scientific validity, analytical and clinical performance), the benefit-risk assessment and risk management documentation, Post-Market Surveillance (PMS / PSUR) documentation as well as Instructions for Use (IFU) and Summary of Safety and Performance (SSP) Assess applicable IVDR regulatory requirements, including device classification, conformity assessment routes, performance evaluation, and consultation procedures where applicable Identify deficiencies, prepare clear questions, and support communication with manufacturers during iterative review cycles Prepare structured assessment reports in line with notified body processes Collaborate with international and cross-functional experts, including clinical, QMS, software, AI, and regulatory specialists, in multidisciplinary assessment teams Your Qualifications University degree in medicine, pharmacy, engineering, biology, microbiology, chemistry, biomedical sciences, laboratory medicine, molecular diagnostics, or another relevant life science discipline Expertise in in vitro diagnostics, laboratory testing, performance evaluation, or relevant biomedical technologies is required; experience with EU regulatory assessment processes is an advantage Professional experience in the field of healthcare products, in vitro diagnostics especially to detect infectious agent, or related activities such as in vitro diagnostics (IVD), Regulatory affairs / compliance, clinical/performance evaluation, quality management or product development Experience in design, manufacture, testing, validation, verification, clinical or laboratory use, regulatory submission, or assessment of IVD devices or relevant technologies is desirable Solid understanding of IVDR (EU) 2017/746 and relevant guidance documents; knowledge of Korean regulatory expectations for IVDs is an advantage Strong analytical skills and ability to assess complex scientific data as well as experience in reviewing or preparing technical documentation are an advantage Fluency in Korean and English / Good communication and writing skills in English What We Offer Flexible working hours Wellness benefit Meal/Mobile phone allowance support Employee Benefit Points 2days of annual leave for 1month of perfect attendance Training & growth opportunities Additional Information Contract type : Permanent Please submit below required documents as PDF file. Korean resume English resume You don’t meet every single requirement? No problem — we encourage you to apply if this role excites you. We welcome applications from people of all backgrounds, experiences, and perspectives. At TÜV SÜD Group, we have employees from more than 100 different countries collaborating together. People of different backgrounds, skills, and pursuing different life goals. Our strength comes from these countless and varied perspectives. We are committed to be an inclusive and diverse workplace by welcoming people of all backgrounds. We want Diversity & Inclusion (D&I) to be a foundation of our company and create an environment where all our employees can trust they will be treated with respect, regardless of gender, nationality, ethnic background, faith, beliefs, disabilities, age, sexual orientation, or identity. As such, our employees are expected to behave at all times in a manner consistent with TÜV SÜD Group Code of Ethics and Company values. We firmly believe embedding D&I in the heart of what we do will inherently contribute to the success of TÜV SÜD Group. Click here to find out more about Diversity at TÜV SÜD Group. Work Area: Medical Devices & Healthcare Country/Region: Korea (the Republic of) Job Location: Seoul (Yeongdeungpo) Working Model​: Hybrid Employment Type: Full time / regular Company: TUV SUD Korea Ltd. Org Unit Code: Requisition ID: 6766 Duration in months (if limited contract):