ivd

ppDo you bring deep experience in IVD or companion diagnostic product development and a track record of leading complex programs through regulatory approval or pivotal clinical trials? Can you align cross-functional teams and biopharma partners around the scientific, regulatory, operational, and commercial milestones needed to deliver diagnostic solutions?...

pTÜV SÜD in Zürich is seeking a professional in Medical Devices Healthcare to perform Technical Documentation Assessments (TDA) for IVD devices according to IVDR requirements. Your expertise will be central to ensuring compliance and quality in evaluation processes. /ppThe ideal candidate holds a university degree in life sciences or a comparable field,...

SOPHiA GENETICS in Vaud, Switzerland invites you to a six-month internship in Quality Management and Regulatory Affairs, supporting compliance of in vitro diagnostic (IVD) medical devices. You’ll work on real projects alongside experienced colleagues to ensure regulatory and quality standards are met.You’ll collaborate with R&D, QA and Regulatory Affairs...

SOPHiA GENETICS offers a six-month internship in Quality Management and Regulatory Affairs to support the compliance of our in vitro diagnostic (IVD) medical devices. You’ll work alongside experienced colleagues on real projects, ensuring regulatory and quality standards are met across the lifecycle.You’ll gain hands-on experience reviewing regulatory...

Roche Holding AG in der Region Zug sucht eine visionäre Führungskraft als Technical Project Leader im NPC Development Standards & Product Risks. Sie steuern globale Initiativen, bringen Regulierungserfahrung ein und arbeiten eng mit Regulatory Affairs, Operations sowie Führungskräften weltweit zusammen.Sie verantworten Planung, Ressourcen und Budget,...

pSOPHiA GENETICS is seeking a Program Leader for Diagnostics Solutions in Rolle, Switzerland. The hybrid role focuses on end-to-end IVD/CDx development programs, coordinating cross-functional teams through validation, regulatory submissions, and commercial launch. /ppYou will collaborate with Biopharma partners, manage budgets, and drive alignment across...

pActalent is seeking a Product Quality Engineer to drive quality activities in a regulated environment. The role emphasizes test equipment qualification, test method validation, and robust test planning across internal and external suppliers. /ppYou will translate specifications into URS, define acceptance criteria, and lead qualification efforts while...

ph3About the company /h3pAt 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...

pSOPHiA GENETICS is seeking a Senior Clinical Affairs Manager to own the clinical performance strategy for validation work in an IVD/molecular diagnostics context. You will partner closely with Regulatory Affairs, Clinical Operations, CROs, and external partners to design and deliver robust clinical studies with strong evidence. /ppThis is an individual...

pMany tests in maternal and reproductive health can only be done in a hospital or clinic. Rea Diagnostics, an EPFL spin-off, is developing tests that patients can use in the comfort of their home. /p pToday, a woman with symptoms of preterm labor has to go to the hospital for an exam that tells her and her doctor whether she is at risk of imminent delivery....

pEVIIVE is seeking a motivated Regulatory Affairs Lead to guide our diagnostic platform through early clinical and in-house IVD regulatory pathways. You will lead documentation for Swiss IvDO compliance, support QMS implementation, and prepare submissions for IVDR and FDA pathways. /ppYou will define strategy across CH/EU/US, draft essential regulatory docs,...

At SOPHiA GENETICS, we are building the future of AI-assisted, data-driven medicine. Our technology helps healthcare professionals make sense of complex data, with the ambition of improving outcomes for patients with cancer and rare diseases. Behind every medical technology are rigorous quality processes and regulatory requirements that help ensure its...

At SOPHiA GENETICS, we are building the future of AI-assisted, data-driven medicine. Our technology helps healthcare professionals make sense of complex data, with the ambition of improving outcomes for patients with cancer and rare diseases. Behind every medical technology are rigorous quality processes and regulatory requirements that help ensure its...

At SOPHiA GENETICS, we are building the future of AI-assisted, data-driven medicine. Our technology helps healthcare professionals make sense of complex data, with the ambition of improving outcomes for patients with cancer and rare diseases. Behind every medical technology are rigorous quality processes and regulatory requirements that help ensure its...

SOPHiA GENETICS, Rolle, Switzerland, offers a six-month internship in Quality Management and Regulatory Affairs. You will work with experienced colleagues on real projects to support regulatory compliance for our in vitro diagnostic devices.This paid internship develops hands-on skills in ISO 13485, IEC 62304 and GDP, including change control, non-conformity...

ITech Consult AG in Rotkreuz, Switzerland, is seeking a Systems Engineer (m/f/d) to join the NPC R&D BGE Systems Development and Integration team. You will define requirements, manage system architectures and collaborate across hardware, software, operations, and regulatory affairs to deliver robust BGE analysis systems.The ideal candidate has 3–5 years in...

SOPHiA GENETICS in Vaud, Switzerland invites you to a six-month internship in Quality Management and Regulatory Affairs, supporting compliance of in vitro diagnostic (IVD) medical devices. You’ll work on real projects alongside experienced colleagues to ensure regulatory and quality standards are met. You’ll collaborate with R&D, QA and Regulatory...

Many tests in maternal and reproductive health can only be done in a hospital or clinic. Rea Diagnostics, an EPFL spin-off, is developing tests that patients can use in the comfort of their home. Today, a woman with symptoms of preterm labor has to go to the hospital for an exam that tells her and her doctor whether she is at risk of imminent delivery. We...

Rea Diagnostics SA in Lausanne, Switzerland, seeks a Quality Assurance professional to develop, implement and monitor the QMS in compliance with ISO 13485 and IVDR 2017/746. You report to the Management Representative and collaborate closely with R&D and Production during clinical evaluation stages.You will drive QA activities across teams, manage the...

Actalent is seeking a Product Quality Engineer to drive quality activities in a regulated environment. The role emphasizes test equipment qualification, test method validation, and robust test planning across internal and external suppliers. You will translate specifications into URS, define acceptance criteria, and lead qualification efforts while...