Clinical Study Manager — Medical Devices (ISO/GCP)
Amaris Consulting
pAmaris Consulting is seeking a Clinical Study Manager in the Netherlands to oversee planning, coordination, execution, and oversight of clinical studies for Class I and II medical devices. You will ensure regulatory compliance, quality standards, and effective collaboration across CRAs, CRCs, Data Management, Regulatory Affairs, QA, and RD. /ppApplications require a Master’s or PhD in Life Sciences or related fields and at least 3 years of experience in clinical study management within the medical /p #J-18808-Ljbffr
Vacature geplaatst op 2 dagen geleden
Soortgelijke banen die u mogelijk interesserenOp basis van de vacature Clinical Study Manager — Medical Devices (ISO/GCP) in Eindhoven
- ...tot deze vacature.brpAs a Clinical Study Manager, you will be responsible for... ...and oversight of clinical studies for Class I and Class II medical devices, ensuring compliance with applicable... ...in compliance with ISO 14155, ISO 13485, MDR, GCP, and internal quality procedures...Medische hulpmiddelen
- ...dat u solliciteert met alle gevraagde informatie, zoals uiteengezet in het functieoverzicht hieronder.brYou will join a newly built ISO Class 7 cleanroom at High Tech Campus Eindhoven, working to GMP and ISO 13485 standards in a growing production team. /ppAs a Cleanroom...Medische hulpmiddelen
- ...Consulting in the Netherlands seeks a Senior Clinical Operations Consultant to lead and mentor teams across medical device projects, delivering strategic oversight,... ...and regulatory guidance. You will ensure studies meet ICH-GCP, ISO 14155, FDA requirements, MDR/IVDR, and...Medische hulpmiddelen
- ph3Senior Clinical Operations Consultant - Medical Devices (F/M/X) /h3 pPermanent... ...clinical study execution while... ...oversight of clinical studies throughout the... ...Practice (ICH-GCP), ISO 14155, FDA... ..., Data Management, Safety, RD, and... ...liAbility to manage multiple priorities...Medische hulpmiddelen
- pAmaris Consulting is seeking an experienced Clinical Research Associate to support multiple medical device projects across sponsor‑dedicated trials. You will monitor sites, ensure GCP/ISO 14155 compliance and manage TMF/ISF documentation in a consulting setting. /ppThe...Medische hulpmiddelen
- ppBuilding the clinical evidence for... ...use of the device in patients.... ...cardiology, medical device... ...evidence and study design /h3 ul... ...pre-clinical studies with CARIM /... ...workflow in the clinic /li /ul h3... ..., or GCP/ISO 14155 is beneficial... ...layers of management and no politics...Medische hulpmiddelenMet contractStageFulltimeStartupThuiswerk
- ...software for real-time medical imaging, monitoring, and connected care devices /liliDrive the full software... ...release planning, and manage personal and team... ...quality standards, including ISO 13485 and IEC 62304 /liliFamiliarity... ...! /lilibCase study /b: Depending on the position...Medische hulpmiddelen
- ...Research Associate - Medical Devices (F/M/X) /h3... ...supporting clinical investigations... ...working with study teams, investigators... ...clinical studies involving... ...Clinical Practice (GCP) /b and bISO 1... ...liSupport the management and reporting... ...team: your line manager of course, but...Medische hulpmiddelenStage
- pAmaris Consulting zoekt een Regulatory Affairs specialist voor medical devices in Nederland. Je werkt aan compliance- en registratietrajecten... ...ruime ervaring in regulatory affairs, kennis van EU MDR/IVDR, ISO 13485, ISO 14971 en FDA-vereisten, en uitstekende communicatie...Medische hulpmiddelen
€ 75.000 - € 100.000 per jaar
...different domains like autonomous vehicles, medical device development, the next supercomputer or... ...are used to working in a structured (ISO-13485) development process, have worked... ...to achieve your ambitions; /liliannual study budget and customized training program within...Medische hulpmiddelenStageThuiswerk- ...technology into a validated clinical system — on time /... ...is our first study in patients. Everything... ...regulatory documentation that ISO 13485 and EU MDR... ...specifications, design, risk management, testing) /... ...graduation project in medical device development, RD project...Medische hulpmiddelenMet contractStageFulltime
- pAmaris Consulting is seeking a Senior Clinical Operations Consultant in Eindhoven... ...clinical operations for innovative medical device projects.brOm te solliciteren,... ...role involves strategic oversight and management of clinical studies from planning to execution,...Medische hulpmiddelen
- ..., ontwikkelt regulatory strategieën en werkt samen met stakeholders voor markttoegang. /ppJe bent verantwoordelijk voor EU MDR/IVDR, ISO 13485, ISO 14971 en FDA-regelgeving, stelt technische dossiers en CERs op, bereidt audits voor en begeleidt MDSAP-compliance. /p #J-1...Medische hulpmiddelen
- ...hieronder.brpWe're now moving from clinical milestones into commercial... ...seek the follow-up. In a medical device company, this is real... ...in customer service, order management or customer operations. /liliFluency... ..., or familiarity with ISO 13485 or EU MDR. /li /ulWhy...Medische hulpmiddelenPer direct beginnen
- ...DESCRIPTION Job Title Quality Manager Job Description As Quality... .... Minimum 3 years of experience in a medical device or regulated industry with experience in... ...preferred. Knowledge of MDR Regulations, ISO 13485, and MDSAP standards. Demonstrated...Medische hulpmiddelenFulltimePloegendienst
- ...external suppliers, develop robust test plans and automated testing, mentor junior engineers, and present strategic design proposals to senior management while ensuring compliance with medical device quality standards such as ISO 13485 and IEC 62304. /p #J-18808-LjbffrMedische hulpmiddelen
- ...to design and implement embedded software for real-time medical imaging and connected care devices.brAlle potentiële sollicitanten worden aangemoedigd om... ...xgiwjmb in software or computer science, 6+ years of embedded MCU experience, strong C++, SOLID principles, and ISO /pbrMedische hulpmiddelen
- ...guide multi-client teams. You will implement real-time firmware for Class III medical devices in modern C++ and ensure regulatory alignment. /ppThe role emphasizes regulatory compliance (ISO 13485, IEC 62304, ISO 14971), verification strategies, and hands-on debugging....Medische hulpmiddelenStageStartup
- ...research institutions such asMayo Clinic andMIT. Thanks to our hardware,... ...‑on and experienced Project manager (4-5 days) t to lead multidisciplinary medical device development projects from concept... ...liliUnderstanding of Design Controls, ISO 13485, IEC 62304, and/or EU MDR...Medische hulpmiddelenStage
- ...research institutions such asMayo Clinic andMIT. Thanks to our... ...Affairs Engineer to support our medical device portfolio throughout its lifecycle... ...processes within our Quality Management System /li liSupporting the... ...of EU MDR (2017/745), ISO 13485 and ISO 14971 /li liExperience...Medische hulpmiddelenStage
- ...regulated industries such as pharmaceuticals, medical devices and food production, we are looking for... ...improve the integrated quality management system and ensure that defined standards... ...system as well as strong knowledge of ISO 9001 and ISO 14001; knowledge of ISO 50...Medische hulpmiddelen
- ...from hospital labs to mobile clinics. By helping providers, patients... ...Quality and Regulatory Affairs Manager (UK CH) and will primarily be... ...Regulatory Affairs within the Medical Device and/or IVD industry. /liliLead auditor certification (ISO 9001) /liliWorking knowledge of...Medische hulpmiddelenOp afstand werkenThuiswerk
- ...cutting-edge technological solutions to medical device startups driving neuroscience... ...helping them navigate firmware design, risk management, and regulatory expectations Collaborate... ...compliance with medical device standards (ISO 13485, IEC 62304, ISO 14971) and guide clients...Medische hulpmiddelenStageStartup
- ph3Job Description: Clinical Development Scientist /h... ...alignment. /liliOwns clinical study design, protocol... ...risk and timeline management. /liliLeads site/KOL engagement... ...of Medicine, or Medical Technical degree, or a... ...AI‑based medical devices. /liliExperience in Clinical...Medische hulpmiddelenMet contractFulltime
- ...for our implantable devices at the moment it... ...the transition from clinical supply to... ...compliant, resilient medical device supply chain... ...negotiation, performance management, and (with... ...compliant with EU MDR, ISO 13485 and GMP,... ...your work reach the clinic /li liA culture built...Medische hulpmiddelenFulltime
- ...an Amaris Consulting project within the medical device industry, we are looking for a Technical... ...liCollaborate closely with engineers, product managers, designers and subject matter experts. /... ...your career opportunities! /p h3Case study /h3 pDepending on the position, we may...Medische hulpmiddelenPer direct beginnen
€ 48.000 - € 81.000 per jaar
...for determining dispositions of non-conformances and drives management of Non-Conformances (NC) and Quality Notifications (QN)... ...have a minimum of 2+ years’ experience in FDA regulated (ISO 13485) medical device quality /manufacturing environments, with a focus on quality...Medische hulpmiddelenStageFulltime- ...maintain a robust Quality Management System and support the... ...delivering life‑saving medical technologies to our... ...brliExperience within the medical device, pharmaceutical, life... .../li /brliKnowledge of ISO 9001 and ISO 13485... ...aiming to improve clinical results and optimize workflows...Medische hulpmiddelen
- ...strategic design proposals to senior management. Within Randstad Professional,... ...working in compliance with medical device quality and regulatory standards (e.g., ISO 13485 or IEC 62304). /li liYou... ...Leveraging advanced technology and deep clinical and consumer insights, Philips...Medische hulpmiddelen
- ...institutions such as Mayo Clinic and MIT. Thanks to our... ...we build software for medical imaging, including AI-... ...developed as a medical device (IEC 62304), which means... ...to our quality management system.br/liliPerform exploratory... ...with IEC 62304, ISO 13485, or ISO 14971 (we...Medische hulpmiddelenStage
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