s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »
s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »
s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »
functional teams Experience in root cause investigation and analysis of failures to develop corrective and preventative actions Experience working with regulatory requirements, including AS9100, ISO13485, and IATF 16949, is a plus Experience working with suppliers and customers more »
the company's quality management system (QMS) to ensure compliance with regulatory requirements, including training and audits. Support in 3rd party audits according to ISO13485 and QMSR requirements. Skills and Qualifications: Bachelor's degree in degree in a relevant scientific or engineering field; advanced degree preferred (e.g. more »
Office including Excel, Word, Outlook, PowerPoint, Docusign, Adobe and Adobe Editor an advantage. Knowledge and experience of regulatory systems and approvals including MDR and ISO13485 an advantage. Salary & Benefits £25,000 per annum You'll receive a fantastic benefits package including pension scheme, Private Medical, healthcare cover more »
all levels. Non clinical and clinical experience and being able to input into both RA and Clinical. Previous experience working within the requirements of ISO13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC). Lead more »
PHD and/or MBA within a relevant Scientific, Quality Management, or Engineering field Expertise and proven working experience with current ISO9001:2015 and ISO13485 standards Industry experience in a Quality role and in a Senior Leadership position (department head) Experience of running a medium-sized Life Science organisation Well more »
least one of: electronic devices, embedded software, or application software Proven years direct project management experience Proven record of successful project management within an ISO13485 or similar quality system Proven ability to deliver results through others, both direct and matrixed. Proven ability to build/lead dedicated, passionate teams. Can more »
performance and accuracy of medical technologies.Algorithm Development- Develop prototype algorithmic functions based on data analysis and experimental findings.Quality Assurance: Assist in maintaining adherence to ISO13485 standards and contribute to quality control processes. To be successful in this position you will need:Bachelor's or Master's degree more »
performance and accuracy of medical technologies.Algorithm Development- Develop prototype algorithmic functions based on data analysis and experimental findings.Quality Assurance: Assist in maintaining adherence to ISO13485 standards and contribute to quality control processes. To be successful in this position you will need:Bachelor's or Master's degree more »
digital health apps deployed on mobile devices. 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
digital health apps deployed on mobile devices. 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 »
RG24, Popley, Hampshire, Church End, United Kingdom
Cure Talent Ltd
digital health apps deployed on mobile devices. 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
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 »
Hands-on experience in electronics development within In Vitro Diagnostic (IVD) devices or a similar highly regulated industry. Strong understanding of relevant standards, including ISO13485, IEC 61010, and IEC 60601. Experience with: Motor control, including stepper and DC brushed motors. Temperature control using resistive heaters and Peltier devices. Optical systems more »
Hands-on experience in electronics development within In Vitro Diagnostic (IVD) devices or a similar highly regulated industry. Strong understanding of relevant standards, including ISO13485, IEC 61010, and IEC 60601. Experience with: Motor control, including stepper and DC brushed motors. Temperature control using resistive heaters and Peltier devices. Optical systems more »
Rosyth, Scotland, United Kingdom Hybrid / WFH Options
Optos
to tight deadlines and be able to manage your own time well. It would also be great if you have experience of working with ISO13485 and FDA Medical Device Design Control processes. Life at Optos is fast-paced and everyone tends to chip in. We have an experienced team who more »
rosyth, north east scotland, United Kingdom Hybrid / WFH Options
Optos
to tight deadlines and be able to manage your own time well. It would also be great if you have experience of working with ISO13485 and FDA Medical Device Design Control processes. Life at Optos is fast-paced and everyone tends to chip in. We have an experienced team who 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 »
into the pharmaceutical market About Us: We are a specialized consultancy providing Regulatory Affairs support to the medical device industry. Our expertise spans across ISO13485, European regulations, FDA regulations, and other global standards for medical devices. Join our team and be part of a growing consultancy where more »
london, south east england, United Kingdom Hybrid / WFH Options
Barrington James
into the pharmaceutical market About Us: We are a specialized consultancy providing Regulatory Affairs support to the medical device industry. Our expertise spans across ISO13485, European regulations, FDA regulations, and other global standards for medical devices. Join our team and be part of a growing consultancy where 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 »
Ideally, the Medical Devices company you have worked for has produced handheld or portable Medical Devices, but as long as the device is to ISO13485 standards, we will consider your allocation. You will be rewarded with an excellent starting salary and package while being a part of more »
Procedures (SOPs) * Ensure regulatory requirements are maintained Requirements: * Practical experience in verification preferably of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment * Experience in writing test protocols in line with Product Requirement Specifications * Degree in a Science or Engineering subject * Experience in medical more »
