deployed on mobile devices. Microsoft Azure certifications. Familiarity with FDA/MDR/UK MDR medical device software regulation, including relevant standards such as ISO13485, ISO14971, IEC62304, IEC82304, and IEC62366. Deep understanding of the software development lifecycle (SDLC) and best practices in the medical device industry. You will not be more »
Employment Type: Permanent
Salary: £80000 - £90000/annum Negotiable DOE + Benefits
controlling other medical devices. Microsoft Azure certifications. Familiarity with FDA/MDR/UK MDR medical device software regulation, including relevant standards such as ISO13485, ISO14971, IEC62304, IEC82304, and IEC62366. Deep understanding of the software development lifecycle (SDLC) and best practices in the medical device industry. You will not be more »
Basingstoke, Hampshire, South East, United Kingdom Hybrid / WFH Options
CURE TALENT LIMITED
deployed on mobile devices. Microsoft Azure certifications. Familiarity with FDA/MDR/UK MDR medical device software regulation, including relevant standards such as ISO13485, ISO14971, IEC62304, IEC82304, and IEC62366. Deep understanding of the software development lifecycle (SDLC) and best practices in the medical device industry. You will not be more »
managing or supporting the management of scientific or engineering projects. Ability to work to the Company’s Quality Systems and Policies in line with ISO13485 standards. Advanced experience with Microsoft Word and Excel. Great communication skills. Be eligible to work full time in the UK without restriction. Excellent work ethic more »
concepts to diverse audiences. Strong knowledge of regulatory requirements and quality standards applicable to medical device development and manufacturing, such as FDA regulations and ISO 13485. Our Benefits: 26 days' holiday with the option to buy or sell an additional 5 Up to 10% employer pension contribution Share and more »
Supporting in house and contract engineers in Mechanical Engineering Creation and management of product and production Technical Documentation Manage and maintain engineering data within ISO13485 QMS Engineering management of operations – Design Change, Compliance, Validation etc. Take ownership of engineering drawings and technical documentation relating to technical files more »
At least relevant technical experience Experience in nucleic acid assay development Commercial in vitro diagnostic product development experience Knowledge of Quality Management & Regulatory frameworks (ISO13485, FDA 21 CFR 820, cGMP) Previous line management experience If you're ready to make a substantial impact in the realm of more »
a relevant scientific discipline. Significant (>3 years) relevant technical experience. Nucleic acid assay development experience. Commercial IVD product development experience. Quality Management & Regulatory frameworks, ISO13485, FDA 21 CFR 820 and cGMP. Previous line management experience. Strong laboratory-based background. Attention to detail and well organized. Please share more »
Looking For: * Minimum 3 years of experience in regulatory affairs within the diagnostics industry. * Strong knowledge of IVD device regulations, including 21CFR, IVDR, and ISO 13485. * Excellent communication, writing, and problem-solving skills. * Ability to work effectively in multidisciplinary teams and make informed decisions. * Understanding of when to escalate more »
the LEX Diagnostics team. What you will be doing: Manage the Quality and Regulatory documentation workflows for the LEX Product portfolio and adhere to ISO13485 requirements. Coordinate and facilitate documentation reviews and approvals involving the relevant people Assess the progress and effectiveness of the documentation control system, addressing any errors more »
Caernarfon, Gwynedd, Wales, United Kingdom Hybrid / WFH Options
Siemens Healthineers
professional and personal growth, all while valuing your unique contributions. Apply now for the position Quality Systems Engineer and you will ensure compliance with ISO13485, FDA 21 CFR Part 820 and other international regulatory requirements, and ensure business needs are met through the delivery and operation of vigilance and post more »
Hereford, Herefordshire, West Midlands, United Kingdom
Hunter Selection
robotics are used wherever possible, designing and implementing 6-axis cells and introduction electronic and logic controls to automate where possible. Comply with all ISO13485 requirements. Knowledge, Skills & Experience: An experienced Injection Moulding Technician, with experience of manufacturing products to tight tolerances, using high grade polymers. Demonstrable more »
products and design new ones Lead presentations and liaise with senior management on a daily basis Have a good understanding of IEC60601 family standards, ISO13485, ISO14971 and BSEN62304 This is a highly varied, challenging and interesting role with an employer of choice in Caerphilly. Not only will you benefit from more »
Engineer, Berkshire: - Experienced in mechanical and electrical testing - Experience in both hands-on testing and documentation writing - Experience in highly regulated industries - Experience of ISO13485 is highly desirable For more information or to apply for the Contract Verification Engineer opportunity based in Berkshire, please contact Jack Kelly -/ more »
Cardiff, South Glamorgan, Wales, United Kingdom Hybrid / WFH Options
Gyrus Medical Ltd An ATL Technology Company
advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and NCR and against the external requirements of the relevant regulatory authority (ISO13485, Medical Device Directive MDD 93/42/EEC/Medical Device Regulation (EU) 2017/745 and 21 CFR Part 820) and local quality … orientated qualification Minimum of 3 years experience working in a QA/QS environment, preferably within the medical device or pharmaceutical industry. Knowledge of ISO13485:2003 and Medical Device Directive MDD 93/42/EEC Knowledge of FDA QSR Part 820 Computer literate to include MS Word, Excel and more »
refrigeration specifications are feasible to source by connecting to suppliers and manufacturing operations Provide specific documentation related to product design to meet regulatory compliance: ISO 9001, 13485 and organization requirements Assist on quality complains from the field by providing technical support to identify root cause, short- and long … and heat transfer Design Engineer will have experience working in formalized phase-gate product development process, using Design tools such as DFM, FMEA and ISO 9001 design controls Experience on SolidWorks (CAD) If you would like to find out more about this Design Engineer opportunity, click the "APPLY NOW more »
in electro-mechanical systems development for Class 2A/B medical devices will be pivotal as you ensure compliance with industry standards such as ISO13485 and 21CFR820. Beyond technical prowess, you'll play a key role in crafting meticulous documentation for regulatory submissions, supporting quality activities, and spearheading non-conformance … Experience required: Experience in Class 2A/B (is preferred) medical device especially in electro-mechanical systems development. Familiar with key standards such as ISO13485, IEC60601 and 21CFR820. Knowledge on IEC62304 is desirable. Some project management experience and knowledge on project management methodology. Essential skills: Leadership, application of engineering principles more »
book complying with GLP and GDP. Logging in of test samples. Preparing testing plans and data template ready for testing. Working within a controlled ISO13485 and ISO9001 Laboratory quality system and in accordance with GLP/GMP procedures. Design, plan and execute Physical testing in support of R&D activities … science related discipline. Experience in a working laboratory environment out with academia Understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2000, FDA 21 CFR part 820) and GMP Guidelines and Regulation. Good working knowledge of Microsoft Office, specifically Word and Excel. Have an more »
laboratory sector. The products are supported with a full range of laboratory services as well as comprehensive servicing and repair capability. The company is ISO13485 certified. We have an excellent opportunity in our Services Team for a Service engineer who is looking to build on their experience to date working … the ability to respond to emergencies. Experience of maintenance repairs, such as electrical, and plumbing. To have an understanding of Quality Standards such as ISO13485, ISO9001, ISO14001 or other applicable standards, working with a Quality Management System. Ability to work independently and manage time effectively. Maintain accurate records of maintenance more »
