Technical File Assessor for Ivd Products

vor 3 Wochen


Hamburg, Deutschland TÜV SÜD Product Service GmbH Vollzeit

Seit 1866 gilt unsere Leidenschaft der Technik und der Sicherheit. Innovationen beeinflussen unser Leben in vielfältiger Weise. Für die Sicherheit von Menschen und der Gesellschaft setzen wir uns jeden Tag aufs Neue ein und schaffen Vertrauen in neue Technologien. Wir sind Teil des Fortschritts. Wir beraten, wir prüfen, wir zertifizieren. Wir handeln aus Überzeugung, gestalten schon heute die Welt von morgen - setzen Zeichen. Wir nehmen die Zukunft in die Hand. Wir sind TÜV SÜD - 25.000 Mitarbeiter an weltweit 1.000 Standorten.

**Aufgabe**
- Evaluation of technical documentation, product dossiers and test results of production batches of in-vitro diagnostic products, mostly class D products for blood grouping
- Writing technical reports and interaction with international clients
- Supporting the entire certification project through pro-active problem-solving and effective management of internal interfaces
- Collaboration in an international team for technical assessment of national and interna-tional clients

**Qualifikation**
- Completed master&;s degree in a scientific field, e.g. biology, biochemistry or biotechnolo-gy (PhD is a plus)
- At least four years of professional experience in the diagnostics industry with blood grouping products (e.g. AB0, Rhesus), particularly in design and development
- Sound knowledge of immunology, molecular biology and related techniques
- Enthusiasm, passion and good self-management skills

**Weitere Informationen**
- #Sandra+Heinig



  • Hamburg, Deutschland TÜV SÜD AG Vollzeit

    Aufgabe Evaluation of technical documentation, product dossiers and test results of production batches of in-vitro diagnostic products, mostly class D products for blood grouping Writing technical reports and interaction with international clients Supporting the entire certification project through pro-active problem-solving and effective management of...


  • Hamburg, Deutschland TÜV SÜD AG Vollzeit

    Aufgabe Evaluation of technical documentation, product dossiers and test results of production batches of in-vitro diagnostic products, mostly class D products for blood grouping Writing technical reports and interaction with international clients Supporting the entire certification project through pro-active problem-solving and effective management of...


  • Hamburg, Deutschland TÜV SÜD AG Vollzeit

    Aufgabe Evaluation of technical documentation, product dossiers and test results of production batches of in-vitro diagnostic products, mostly class D products for blood grouping Writing technical reports and interaction with international clients Supporting the entire certification project through pro-active problem-solving and effective management of...


  • Hamburg, Deutschland TÜV SÜD Vollzeit

    Aufgaben Evaluation of technical documentation, product dossiers and test results of production batches of in-vitro diagnostic products, mostly class D products for blood grouping Writing technical reports and interaction with international clients Supporting the entire certification project through pro-active problem-solving and effective...

  • Product Specialist

    vor 4 Wochen


    Hamburg, Deutschland Discover International Vollzeit

    A global notified body in the medical device industry is looking for fully remote Product Specialist.P.s, you need to have R&D experience in the medical device industry to be qualified for this role. ResponsibilitiesRegulatory Compliance: Review and assess technical documentation, including design dossiers, technical files, and risk management files, to...


  • Hamburg, Deutschland The Qt Company Vollzeit

    Our QA Tools are used by thousands of development projects worldwide to guarantee the best code quality before deployment. Those are comprised of various assets, from automated GUI testing to static code analysis. Furthermore, service-based solutions are within our current and upcoming portfolio. We are looking for a Technical Product Manager for the ...


  • Hamburg, Deutschland Radancy Vollzeit

    Overview When the world throws technology challenges at us, we eat them up. And then we ask for more. Welcome to life on the Radancy technology team. Here, you’ll work on our scalable and evolving platform, continually drive innovation, and work on projects to support the recruitment needs for Fortune 100 clients. You'll be part of...

  • Technical Support

    Vor 4 Tagen


    Hamburg, Deutschland DEDIENNE AEROSPACE Vollzeit

    **CONTEXT** Reporting to the Customer Service Manager, as a technical support & buyer, you will guarantee the availability of spare parts for the team of Customer Service technicians by purchasing products/mechanical sub-contracting services on the best terms, considering technical and commercial objectives and the normative and regulatory requirements...


  • Hamburg, Deutschland ABOUT YOU Vollzeit

    At SCAYLE Payments, Product Managers help build innovative payments products our customers love. Product development is an extremely collaborative effort between finance, risk & compliance, engineering, and customer-facing teams. In order to grow, we are seeking a highly skilled and experienced Senior Technical Product Manager (m/f/d) to join our dynamic...

  • Technical Trainer

    vor 2 Wochen


    Hamburg, Deutschland Hiab Vollzeit

    MacGregor is a leader in sustainable maritime cargo and load handling with a strong portfolio of products, services and solutions. Shipbuilders, shipowners and operators are able to optimise the lifetime profitability, safety, reliability and environmental sustainability of their operations by working in close cooperation with MacGregor. Shape your...


  • Hamburg, Deutschland Wallee Vollzeit

    Technical Support Specialist 60% - 100%Wallee is one of the most innovative fintechs in the field of payment and payment processing. We offer you the opportunity to work in a start-up in an international and agile environment. Wallee AG creates software components for payment processing in e-commerce and retail. Our customers and partners include...


  • Hamburg, Deutschland Adaptive Life Science Vollzeit

    _Passionate about making a difference in the medical technology industry? _ - Do you love working with technical documentation, in regulatory affairs or quality management?_ - We want to hear from you!_ **Overview**: My client is a leading manufacturer and supplier of high quality ENT treatment units and diagnostic devices for hospitals and private...


  • Hamburg, Deutschland Taylor Hopkinson | Powered by Brunel Vollzeit

    Opportunity to join a leading EV Charger company, you can work in Hamburg office or 100% work remotely.In this role, you will play a crucial role in leading the technical support team across Europe for EV charging solutions. You will be responsible for providing after-sales engineering support to our clients in the utility industry, ensuring their...


  • Hamburg, Deutschland Kvadrat AS Vollzeit

    Are you looking to join a design company that is taking an active part in contemporary culture, and furthering your career in an international environment? Kvadrat is the world's leading manufacturer of design têxtiles. We supply architects, designers and private consumers across the world with têxtiles and têxtile-related products. For our Product...


  • Hamburg, Deutschland AD Energy Recruitment Vollzeit

    AD Energy is in exclusive partnership with a global leader in solar inverter technology, committed to providing innovative and reliable solutions for renewable energy systems! The organisation has a strong focus on sustainability and cutting-edge technology, serving customers worldwide with high-quality products and dedicated support! We are on the search...

  • Technical Support

    vor 4 Wochen


    Hamburg, Deutschland Zealous Consultancy Vollzeit

    **Important Note: German at a native level both spoken and written is essential for this role** **The role is Hybrid (2 to 3 days in the office)** Our Client based in Hamburg is looking for a Technical support Engineer. They enable a internet connection for a wide range of IoT devices - from smart washing machines to connected cars. Join the team and grow...


  • Hamburg, Hamburg, Deutschland Beiersdorf Shared Services Vollzeit

    At Beiersdorf, we want to help people feel good about their skin – and our commitment goes far beyond caring for skin. For 140 years, we have developed innovative skin and body care products for well-known brands such as NIVEA, Eucerin, La Prairie, Hansaplast, and Labello. We act according to our purpose, WE CARE BEYOND SKIN, and take responsibility for...


  • Hamburg, Deutschland CWS Vollzeit

    Think Circular - sustainability as a business model. This is CWS. With innovative, sustainable and digital rental solutions, CWS contributes to a healthier and safer future. The CWS portfolio is divided into products and services in the areas of hygiene, floor care, work clothing, fire protection, clean rooms and healthcare. The CWS group belongs to Haniel,...


  • Hamburg, Hamburg, Deutschland ETAP - Operation Technology, Inc. Vollzeit

    EinleitungTechnical Sales Manager DACHAbout UsETAP (part of the Schneider Electric group) provides market-leading software solutions for electrical systems, from design and engineering to operations and maintenance. Through its integrated electrical digital twin platform, ETAP delivers best-in-class, seamless customer experience and cloud-leveraging...


  • Hamburg, Hamburg, Deutschland TikTok Vollzeit

    About UsTikTok is the leading destination for short-form mobile video. Our mission is to inspire creativity and bring joy. TikTok has global offices including Los Angeles, New York, London, Paris, Berlin, Dubai, Singapore, Jakarta, Seoul and Tokyo.Why Join UsCreation is the core of TikTok's purpose. Our platform is built to help imaginations thrive. This is...