Technical Documentation Assessor of IVD Medical Devices

vor 2 Monaten


Munich, Deutschland TÜV SÜD Vollzeit

Aufgaben

Assessing technical documentation, product dossiers and test results of production batches of in-vitro diagnostic products, most high-risk products as part of product conformity assessments according to the requirements of the IVDR

Preparing reports included deficiency reports in case of non-conformities according to the requirements of the In Vitro Diagnostic Medical Devices Regulation 2017/746

Delivering high-quality, reliable, and predictable services within defined timeframes

Serving as an internal point of contact for TDA matters as part of the interfaces with other departments, offering support of and close exchange with colleagues

Independent supervision of certification projects for our international customers as a project manager

Readiness for intensive familiarisation with the ISO 13485, ISO 9001, MDR and MDSAP standards

Optionally providing support during QMS audits of medical devices manufacturers according to ISO 13485

Possibility of attending medical conferences

Qualifikationen

University degree in a scientific studies, e.g. chemistry, biotechnology, biochemistry, bioengineering or comparable field of study (PhD is a plus)

At least four years of professional experience in the manufacturing environment of the health care sector, e.g. with a manufacturer of medical devices

At least two years of well-founded hands-on practical experience at design and development, quality management, manufacture, testing or regulatory affairs department is a plus

Experience in creating or evaluating of technical documentation including high risk medical devices with the currently applicable product standards and regulatory requirements according to IVDR

Sound knowledge of immunology, molecular biology and related techniques

Fluency in written and spoken English

Proven qualification as an auditor or quality manger is a plus

Excellent organisational and professional communication skills

Ability to work in a team, pronounced customer orientation and good self-organization

Curiosity and willingness to learn

Experience working with MS Office applications and programs



  • Munich, Deutschland TÜV SÜD Vollzeit

    Aufgaben Assessing technical documentation, product dossiers and test results of production batches of in-vitro diagnostic products, most high-risk products as part of product conformity assessments according to the requirements of the IVDR Preparing reports included deficiency reports in case of non-conformities according to the requirements of the...


  • Munich, Deutschland TÜV SÜD Vollzeit

    Aufgaben We are currently looking for a Medical Device Auditor to join our Medical and Health Service team! You will be performing the audit for medical device manufacturers and ensuring that their Quality Management System (QMS) complies with Medical Devices – including the Medical Device Regulation (MDR) / In Vitro Diagnostic Medical Devices...


  • Munich, Deutschland TÜV SÜD Vollzeit

    Aufgaben We are currently looking for a Medical Device Auditor to join our Medical and Health Service team! You will be performing the audit for medical device manufacturers and ensuring that their Quality Management System (QMS) complies with Medical Devices – including the Medical Device Regulation (MDR) / In Vitro Diagnostic Medical Devices...


  • Munich, Deutschland Wertefest GmbH Vollzeit

    **Who we are**: We support and empower medical device manufacturers by working closely with their teams during the development lifecycle. Our team of engineers masters the complexity of medical devices incorporating high-end robotics and SW solutions with artificial intelligence. Our approach relies on knowledge transfer to the teams by offering training and...

  • Medical Expert

    Vor 4 Tagen


    Munich, Deutschland Consulteer Vollzeit

    **Medical Expert**: Treibe den Ausbau unseres Medical Portfolios voran MUNICH **Deine Rolle & Verantwortlichkeiten** - Aufbau/Umsetzung ISO13485 sowie FDA-Anforderungen **Erforderliche technische & fachliche Expertise** - langjährige Projekterfahrung mit Referenzen im Umfeld - MDD/MDR und/oder IVD/IVDR - IEC 62304 SW-DEV für Medical Devices - ISO 14971...


  • Munich, Deutschland Natus Medical Incorporated Vollzeit

    **Technical support in-house / hotline** (M/F/d)** We are a world-leading manufacturer in the field of medical technology and deal with technically sophisticated products for the screening, detection, treatment, monitoring and tracking of health problems, such as epilepsy, hearing and sleep disorders and neurological disorders. We offer an extensive product...


  • Munich, Deutschland ZEISS Group Vollzeit

    Your Role- The Product Security Officer (PSO) for Medical Devices is a member of the Medical Device Security team at Carl Zeiss Meditec AG and reports directly to the Information Security Manager Medical Devices- The PSO Medical Devices manages, consolidates, prioritizes, and coordinates with the global Information Se-curity Manager (ISM) Medical Devices all...


  • Munich, Deutschland ZEISS Group Vollzeit

    Your Role- The Product Security Officer (PSO) for Medical Devices is a member of the Medical Device Security team at Carl Zeiss Meditec AG and reports directly to the Information Security Manager Medical Devices- The PSO Medical Devices manages, consolidates, prioritizes, and coordinates with the global Information Se-curity Manager (ISM) Medical Devices all...


  • Munich, Deutschland BAXTER Vollzeit

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...


  • Munich, Deutschland Analog Devices Vollzeit

    Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably...

  • Medical Device Trainer

    vor 2 Wochen


    Munich, Deutschland OncoBeta GmbH Vollzeit

    As an innovative company, we are characterized by: - our flat hierarchies - our clearly defined mission - our customer-oriented approach - and a highly motivated team To support the further development of our strategy in Italy, we are looking for a business developer with strategic thinking skills and proactivity: **Medical Device Trainer (f/m/d) full...


  • Munich, Deutschland HENSOLDT Vollzeit

    Company HENSOLDT Sensors GmbH Full time / Part time: The position can be filled in full or part time. Summary For the "Documentation and Training" department within the "Customer Services" division, we are looking for a "Technical Documentation Editor (f/m/d)" at the Taufkirchen site as soon as possible. The main tasks of the "Documentation and...


  • Munich, Deutschland HENSOLDT Vollzeit

    Company HENSOLDT Sensors GmbH Full time / Part time: The position can be filled in full or part time. Summary For the "Documentation and Training" department within the "Customer Services" area, we are looking for a "Team Leader in Technical Documentation for Defense Electronics Products (M/F/d) at the Taufkirchen location at the earliest...


  • Munich, Deutschland TÜV SÜD Vollzeit

    Aufgaben Overall accountable for medical devices customers, all their projects, certificates, complaints and the communication with the client Accountable for P&L of the related medical devices customer, this includes revenue and costs/ressources needed for a project Accountable for A2C (timeliness of every project including all project...


  • Munich, Deutschland TÜV SÜD Vollzeit

    Aufgaben Overall accountable for medical devices customers, all their projects, certificates, complaints and the communication with the client Accountable for P&L of the related medical devices customer, this includes revenue and costs/ressources needed for a project Accountable for A2C (timeliness of every project including all project...


  • Munich, Deutschland Analog Devices Vollzeit

    Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably...

  • Technical Writer

    Vor 4 Tagen


    Munich, Deutschland commercetools Vollzeit

    At commercetools, we are: - **Engaged**: We didn't become the fastest growing, highest-ever valued SaaS software company in digital commerce with nearly 100% year-over-year growth by sitting on the sidelines. - **Inspired**: We continually explore what's possible. As the founder of the headless commerce concept, the leader in true composable commerce, and...

  • Project Engineer

    Vor 4 Tagen


    Munich, Deutschland Brainlab Vollzeit

    Job Description As a Project Engineer for the Snke Viewing team at Snke, you will be part of a growing interdisciplinary team that creates a patient-privacy-centered ecosystem for data-driven healthcare and rethinks all aspects from data capture and visualization to analysis. You will play a vital role in the development and implementation of software...

  • Project Engineer

    Vor 4 Tagen


    Munich, Deutschland Snke OS Vollzeit

    Job DescriptionAs a Project Engineer for the Snke Viewing team at Snke, you will be part of a growing interdisciplinary team that creates a patient-privacy-centered ecosystem for data-driven healthcare and rethinks all aspects from data capture and visualization to analysis. You will play a vital role in the development and implementation of software...


  • Munich, Bayern, Deutschland Snke OS GmbH Vollzeit

    Snke OSTM is a universally deployable digital B2B platform, founded in 2020 & headquartered in Munich. Emerging technologies continue to drive a digital transformation in the healthcare economy. Our founders recognized the potential for value creation by decoupling & deploying their best-in-class platform & team so that other companies can scale up &...