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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):
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