Product Reviewer (IVD Clinical Review / E-ICR) (m/f/d)
Innovations bring profound changes and influence our lives in a variety of ways. At the TÜV SÜD Group, we are highly striving to be an important part of this development and progress. We are here from the beginning and accompany this process. We ensure a safe and sustainable future and create confidence in new technologies. We advise, we check, we certify. For the safety of people and society, we are asking ourselves out every day. We act out of conviction, already today shape the world of tomorrow – set signs. We take the future into our hands. We're the TÜV SÜD group. The TÜV SÜD Group has been synonymous with safety, quality and sustainability since 1866 and is today an international service group with 30,000 employees worldwide. Independently and objectively, the TÜV SÜD Group ensures consumer confidence. .
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Your tasks • Your profile • What we offer
Responsible for clinical oversight for IVD products Assessment of full technical documentation according to IVDR Assessment of clinical performance for e.g. novel devices, CDx, class D, etc.) Evaluate clinical evidence and performance documentation, including scientific validity, analytical performance, and clinical performance Review planning, conduct, monitoring and results of performance for IVD medical devices Assess the state-of-the art, clinical relevance and medical plausibility of intended purpose, claims, target population, and benefit-risk considerations Identify deficiencies, prepare structured review comments, and participate in iterative review cycles with manufacturers and internal stakeholders (e.g. product reviewer). Prepare clear and well-structured assessment reports in line with body quality processes Collaborate with cross-functional experts search as product reviewers, QMS auditors, software experts, and other technical specialists in multidisciplinary assessment teams Internal Support in product classification Oversight and assessment of various European national databases for Field Safety Notice Records
The role requirements are based on IVDR expectations for notified body personnel and the internal qualification framework for E-ICR (Expert for IVD Clinical Review): University degree in medicine, pharmacy, biochemistry, genetics, biology, biomedical science, biotechnology, laboratory medicine, or another relevant scientific discipline Minimum of 4 years of professional experience in the in vitro diagnostic medical device sector, medical devices, medicine, or laboratory medicine At least 2 years of practical experience in planning, conducting, or monitoring performance studies, or in assessing clinical evidence generated from performance studies of IVD medical devices Direct work experience in a healthcare or laboratory setting in which in vitro diagnostic devices are used is a strong advantage Experience in conducting or monitoring clinical performance studies, or in assessing data generated from search, in relevant clinical areas such as blood grouping, tissue typing, oncology, genetics, infectious diseases, and/or physiological markers Solid understanding of IVDR requirements, clinical evidence, performance evaluation, harmonized standards, common specifications, and applicable guidance documents Strong analytical skills and the ability to assess complex scientific and medical data in a structured and objective manner Date of birth: Fluent in English (written and spoken) Structured and independent working style Very good MS Office skills
Flexible working hours: Our flexible working hours allow you to adapt your working hours to your personal needs. Special payments: In addition to a market-oriented salary, we offer attractive special payments such as e.g. a consolidated profit premium or other performance-oriented salary components. Operational Health Management: Our operational health management includes e-Gym Wellpass, which provides you with access to a variety of fitness and health services, as well as an occupational pension scheme that helps you to provide care for your future. Further Benefits: Learn more about our numerous other benefits at https://www.tuvsud.com/de-de/karriere/was-wir-biet At the TÜV SÜD Group, people from more than 100 nations work together. People with different backgrounds, skills and goals. Our strength lies in these numerous and diverse perspectives. We commit ourselves to being an inclusive and diverse employer by welcoming all people. Diversity and integration is the foundation of our company and we promote an environment where all our employees can trust that You are treated with respect - regardless of age, nationality, ethnic background, disability, gender and gender identity or sexual orientation, religion or worldview. We expect our employees to behave at any time in accordance with the Ethics Code of the TÜV SÜD Group and the company values. Applications for people with disabilities are expressly desired and are considered preferred if You are otherwise essentially of the same suitability. We firmly believe that the constant anchoring of these values will continue to contribute significantly to the success of the TÜV SÜD Group. Click here to learn more about diversity at the TÜV SÜD Group. .
Location
 | TÜV SÜD | |
| 80331 München | ||
| Germany |
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