ivdr

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,...

Rea Diagnostics SA seeks a Quality Assurance professional to develop, implement, and monitor our QMS in line with ISO 13485 and IVDR 2017/746. You report to the Management Representative and drive QA activities across teams.The role covers supplier management, training, CAPA and SCAR processes, plus contributing to regulatory submissions and technical...

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...

ppProclinical sucht einen Verification Compliance Specialist, der für einen sechsmonatigen Vertrag in ein Regulierungsteam aufgenommen wird. In dieser Rolle überprüfen und bewerten Sie unabhängig Medizinprodukte von Drittanbietern sowie In-vitro-Diagnostik auf die Einhaltung europäischer (EU-MDR, EU-IVDR) und Schweizer (MepV, IvDV) Vorschriften. Diese...

pProclinical sucht in Zürich einen Verification Compliance Specialist für einen sechsmonatigen Vertrag im Regulierungsteam. Sie prüfen unabhängig Medizinprodukte von Drittanbietern sowie In-vitro-Diagnostik auf Konformität mit EU-MDR, EU-IVDR und den Schweizer Vorschriften. /ppSie arbeiten eng mit Lieferanten und Partnern zusammen, prüfen technische...

pTrelleborg Sealing Solutions is seeking a Regional Quality Manager for Europe to lead and continuously improve the QMS across Europe, ensuring compliance with FDA, MDR/IVDR, and other regulations. The role provides direct quality leadership for Stein am Rhein and supports acquisitions and supplier quality across European sites. /ppYou will lead regional...

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,...

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...

ppTrue to the vision "We drive innovation to improve people's lives", the Hamilton companies have been providing solutions for the health sector since 1950. We are an innovative pioneer in the fields of ventilators, automated pipetting, sample management and in the development of process sensors. /p pThe Business Unit Robotics develops, produces and...

pBlank or asking you to sign in? Switch to the text version or open the original. /p pEVIIVE AG is looking for a motivated and detail-oriented 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...

ppbClinical Study Manager | IVD | Oncology | Lausanne, Switzerland /b /ppbSector: Medical Diagnostics / Life Sciences /b /ppbLevel: Clinical Study Management /b /ppbCompany: Confidential, early-stage startup /b /ppI'm currently working on a confidential search for a Clinical Study Manager to join an exciting, early-stage healthcare technology startup based...

Do you bring a strong background in clinical affairs, clinical science, or clinical operations within IVD or molecular diagnostics? Have you designed clinical performance studies and shaped clinical evidence strategy in an IVDR, CE-IVD, or companion diagnostics environment? If this sounds like you and you are driven by purpose, join the SOPHiA GENETICS team...

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....

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...

Sista ansökningsdag Plats: CHE - Stein am RheinThe Regional Quality Manager for Trelleborg Medical Solutions (TMS) – Europe leads and continuously improves the Quality Management System (QMS) across Europe, ensuring quality, regulatory compliance, and operational excellence in alignment with global quality strategy. The role provides direct quality...

ph3Overview /h3pbProduct Quality Assessor (m/w/d) CAPA SCAR GMP Medical Devices / Rotkreuz /b Projekt: Das Global External Manufacturing Team ist auf Einweg-Spritzgussteile im diagnostischen Umfeld spezialisiert und verantwortet die Entwicklung neuer Verbrauchsmaterialien, Produktpflege sowie die Sicherstellung der Versorgung. In enger Zusammenarbeit mit dem...

pWe are looking for a bProduct Quality Engineer /b to support quality activities within a regulated environment. The role focuses on ensuring that products and test processes meet applicable quality and regulatory requirements, with particular emphasis on btest equipment qualification, test method validation, test planning, and statistical sampling /b....

Senior Projektleiterin / Senior Projektleiter – Schwerpunkt «Medical Devices Applications» In unserem Entwicklungszentrum in Wil realisieren wir Produkte für führende, zukunftsorientierte Unternehmen. Wir unterstützen unsere internationalen Kunden bei Innovationen, neue Technologien und überführen die Produktentwicklungen in die Serienproduktion...

h3Job Description Summary /h3pLocation: Carlsbad, California /ppThe Manager, Quality Systems will serve as a Quality subject matter expert, providing oversight to support commercialization readiness and the continued effectiveness of the Quality Management System. This role will develop and maintain statistically sound, risk-based approaches for evaluating...