15 ISO 13485 Jobs in England with Remote Work Options

Position : Medical Device Regulatory Specialist Suitable for : Regulatory Affairs Specialist with strong experience of ISO 13485 and MDD and MDR Location : Hybrid, ideally Surrey based, with the expectation to travel to Milton Keynes and Surrey sites if required (approx. once a month) + client travel as and when … require experience in the context of Software as a Medical Device (SaMD) to qualify for this position, as well as an essential requirement of ISO 13485 and DCB0129. Essential: • Min 3 years’ experience as Medical Device Regulatory Specialist, Regulatory Affairs Specialist with medical device experience • Good working experience … Medical Device Directive/Medical Device Regulation transition process. • Up-to-date working knowledge of: MDD and MDR (Class 1 & 11a devices) BS EN ISO 13485, 14971, 14155, 27001 BS EN IEC 60601 BS EN 62304 NHS DCB0129/DCB0160 UK General Data Protection Regulation • Good working knowledge more »

primed for you as an individual who is well versed in Quality Engineering within the medical technology sector. Areas such as MDR, MDD and ISO 13485 will be second nature to you as this opportunity will allow you to be the subject matter expert for the business, to … week from home. What will you be doing as their next appointed Quality Systems Engineer? Perform internal quality audits in line with their accreditation (ISO 13485) against work instructions, manufacturing proceedures etc. Maintain and support their Improvement Culture, using your insight and analysis from performing audits as to … with other internal stakeholders on QMS related activities. Ready to apply? This is what you will need to demonstrate; Qualified/Certified Auditor for ISO 13485 (please note, this is a deal breaker for our client) Hands on knowledge of IS0 3485 i.e. you have worked in medical more »

of design and development documentation across various platforms. In this role, you'll offer documentation support for both new and existing projects within the ISO 9001 and ISO 13485 Quality Management Systems. We're looking for someone with a demonstrated track record in maintaining documentation within quality … technical documentation role, with expertise in administering technical/quality documentation that may be subject to audit or inspection by external bodies. Familiarity with ISO standards (particularly ISO 13485/9001) and other quality management systems (e.g., 27001) is highly desirable. Additionally, strong writing skills, teamwork abilities more »

based care. The concentration of the role is the production of software medical device technical documentation in compliance with the Medical Device Regulation and ISO 13485 (Medical Devices). Some input will also be required to support ongoing compliance with other ISO standards. Suitable candidates will have … Directive/Medical Device Regulation transition process. Up to-date working knowledge of the following: MDD and MDR (Class 1 & 11a devices); BS EN ISO 13485, 14971, 14155, 2700; BS EN IEC 606; BS EN 62304; NHS DCB0129/DCB0160 Additionally, you will have the following: Good working more »

devices. Microsoft Azure certifications . Familiarity with FDA/MDR/UK MDR medical device software regulation is essential including applicable standards such as ISO 13485, ISO 14971, IEC 62304, IEC 82304, and IEC 62366. Deep understanding of software development lifecycle (SDLC) and best practices in the more »

5+ years’ industry experience. Desirable: Previously involved in the development of wellness and/or medical devices. Experience coding to MISRA standards. Experience writing ISO 62304-compliant software (class A) under an ISO 13485 quality management system. Good understanding of wireless protocols, particularly Wi-Fi and Bluetooth. more »

products Excellent communication and interpersonal skills for client and colleague relationship-building Experience in team management (preferably Agile methodologies) BONUS POINTS FOR: Familiarity with ISO 9001 and ISO 13485 standards for medical device projects Background or experience with a design consultancy engineering environment Breadth of skills is more »

CAP, ISO15189 laboratory requirements Experience in CLSI, NYDOH and other industry standards for assay validation; Understanding of IVD regulations including QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have more »

reliability, and safety of medical devices throughout the development lifecycle. - Support the development of risk management documentation, in accordance with regulatory requirements such as ISO13485 and FDA guidelines. Qualifications: - Bachelor's degree in Engineering, Computer Science, or related field. Master's degree preferred. - Proven experience in systems engineering within the … medical device industry, including knowledge of regulatory requirements such as ISO 13485 and FDA guidelines. - Strong understanding of systems engineering principles, including requirements analysis, system design, integration, testing, and validation. - Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders. - Experience with risk more »

in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO 13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »

in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO 13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »

hire a Quality Engineer to join their team ASAP. Quality Engineer Role Overview : Responsibility for ensuring the implementation of process and their compliance to ISO 13485. Develop, implement and maintain quality assurance processes and support the Manufacturing Quality Team Lead on the promotion and awareness of Quality; Support the more »

when required ROLE REQUIREMENTS · 5 years minimum of relevant medical and healthcare product design experience · Degree in Design or Engineering related discipline · Familiarity with ISO 13485 working processes · Motivation towards the application of human factors to product development · Excellent 3D CAD skills (preferably SolidWorks) ABOUT US At Oxford more »

Support engineers and contract engineers in mechanical engineering. Create and m anage product and production technical documentation. Maintain the companys engineering data , within a ISO13485 QMS. Have responsibility for engineering drawings (BS 8888) and technical documentation , reports relating to technical files for medical devices. Work collaboratively with contracted design agencies more »

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 »