1 to 25 of 51 ISO 13485 Jobs in the UK excluding London

a relevant scientific discipline. Significant (>3 years) relevant technical experience. Nucleic acid assay development experience. Commercial IVD product development experience. Quality Management & Regulatory frameworks, ISO 13485, FDA 21 CFR 820 and cGMP. Previous line management experience. Strong laboratory-based background. Attention to detail and well organized. Please share 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 »

and developing a positive Quality culture within the organisation. Supporting all other departments to ensure they remain compliant to the accreditations. Primarily, the AS9100, ISO 9001, ISO 13485 (Medical Devices) accreditations for the Company and such other schemes or programs which arise through Customer or market needs … equivalent. Experience (minimum 2 years) in a quality position within a manufacturing/engineering environment. Experience working within one of the following regulated industries: ISO 9001, AS 9100, ISO 13485, IATF 16949. Experience in problem solving and investigation tools such as 8D, CAPA, 5-Whys. Experience in more »

be responsible for ensuring that the systems and processes in place for current Good Distribution Practice, MHRA guidelines, Home Office controlled drugs license and ISO-9001: 2015 and ISO 13485 standards are adhered to and that the procedures and appropriate training for the team and wider DD … Distribution Authorisation, GDP Guidelines 2013/C 343/01, Human Medicines Regulations 2021 relevant MHRA Guidelines, legal requirements, and updates Ensure compliance with ISO 9001: 2015 and ISO 13485: 2016 standards. Ensure the QMS is implemented and maintained. The RP must approve, sign and date, all … environment Minimum 2yrs experience in a quality managers/Management position Detailed knowledge and understanding of Medical Device legislation Good knowledge and understanding of ISO13485:2016 and associated standards Good working knowledge of product classification for medical devices, specifically selecting appropriate classification, and conformity assessment route. Formal Training in ISO13485 more »

NeuroTech AIMDs. Understands the end-to-end process for Class III Medical Devices. Has worked with contract manufacturers or built an internal manufacturing capability. ISO understanding across ISO 13485 requirements. How do I apply? To apply for this outstanding opportunity, please contact Nathan Sasso at Pivotal via more »

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 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 »

To ensure that the project information is well maintained; for example, budget costs, folders, linked projects To ensure compliance to FDA/NPMA/ISO 13485, as well as supporting Medical Device Directive/Regulations documentation Desirable Experience/Qualifications: Degree within project management or a related field 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 »

Desirable requirements Knowledge of medical device regulations such as 21 CFR 820 (QSR) or the 2017/745 MDR and international standards such as ISO 13485 or other regulated industries. Knowledge of Agile Project Management and/or Scrum Methodology. Both Mechanical and Software Development Projects 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 »

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 »

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 »

Aerospace etc.) Proven knowledge and experience of Change Control and Risk Management processes. Engineering or Scientific Degree is highly advantageous. Knowledge and experience of ISO 13485 & ISO 14971 is highly advantageous. If you're seeking an exciting opportunity to be part of a dynamic team driving medical more »

Minimum of 5 years’ experience in developing software and troubleshooting hardware issues. Previous involvement in regulated In Vitro Diagnostic (IVD) development, including operating under ISO13485 and IEC62304. Significant experience in formal software verification Proficiency in C/C++ programming languages. Experience with Real-Time Operating Systems (RTOS) and bare-metal more »

will feed into your constantly evolving test procedure designs. We would love to hear from people who are familiar with industry standards such as ISO 13485, IATF 16949 and you can expect to liaise with the Quality team in terms of compliance and continuous improvement. As a detailed 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 ISO 13485 QMS Engineering management of operations – Design Change, Compliance, Validation etc. Take ownership of engineering drawings and technical documentation relating to technical files more »

sciences company (infectious disease diagnostics, genomics, or lab diagnostics all a bonus) Comfortable working with agile development teams Desirable qualifications: Worked with academic collaborators ISO 13485 understanding SaaS product experience Benefits What we can offer We're a close-knit, collaborative small team. We're building a team 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 »

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 »

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 »

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 »

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 »

the Head of Quality: Strong leadership and mentoring skills. Experience in Electronic Engineering Environment. Demonstrable knowledge and experience in an Electronic Engineering Environment AS9100, ISO 9000, ISO 9001, ISO 13485, TS16949, ISO14001 previous Quality Management experience, (Automotive & Military Customers) Supplier Management), plus having completed successful improvement more »

our diagnostic outputs. Develop and deploy pipeline packages with robust, industry-standard codebases suitable for medical settings. Demonstrate familiarity with development standards such as ISO 13485 and Medical Devices regulations, ensuring compliance in product development. Requirements: Degree in computer science, mathematics, physics, or related fields, with 3+ years … context. Familiarity with model interpretation techniques is desirable. Track record of building and deploying pipeline packages with industry-standard codebases. Knowledge or experience with ISO 13485 and Medical Devices regulations is preferred. Passionate about the mission to transform microbiology diagnostics and combat antimicrobial resistance. Benefits: We offer competitive more »