1 to 25 of 58 Permanent ISO 13485 Jobs in England

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 »

manufacturing. Maintain accurate documentation and lab records. Introduce innovative technologies and make informed recommendations. Manage project scopes, resources, and budgets effectively. Ensure compliance with ISO 13485 standards. Requirements: Essential: Bachelor's degree or higher in a biological-related discipline, with significant post-qualification experience. Minimum of 3 years … experience in people management. Proven ability to lead, motivate, and mentor a team of scientists. Thorough understanding of product design control and ISO 13485 regulations. Extensive experience in molecular biology techniques such as FISH, PCR, DNA manipulation, and fluorescent labelling. Previous work in a regulated, diagnostic environment. Strong … software tools such as BLAST/BLAT and sequence searching methods. Comprehensive knowledge of genomic principles and databases. Additional management experience preferred. Experience in ISO 9001 and ISO 13485 compliant environments, including participation in audits. If you are ready to make a significant impact in a research more »

will be provided to assist carrying out these responsibilities. Main duties will include ? Generating usability documentation for regulatory submission of the product range with ISO practices. ? Leading , running and moderating use studies ? Working closely with the project and wider teams to create a device that meets the customers needs. … travel may be required Candidate Attributes ? Minimum of 2 years experience and relevant qualifications in usability and human factor engineering ? Practical experience ? Knowledge of ISO 13485 Practices. ? Experience in planning and conducting user studies ? Knowledge of use risk management processes ? Documentation writing skills and ability MS office programs … further information or call (01842) 820409 Skills Required Engineer, communication skills, ISO 13485, Risk management, Travelling, Organise meetings, Medical components, Qualifications Required ISO13485, Human factor, Usability, IEC62366 Keywords Engineer, communication skills, ISO 13485, Risk management, Travelling, Organise meetings, Medical Components/ more »

a proven background in In Vitro Diagnostics or Medical Devices. You will have strong experience in the management and/or implementation of an ISO 13485 QMS, CAPA processes and auditing. Key Responsibilities: Develop and Maintain ISO 13485 QMS Support the implementation and transition to an … scientific or technical field Proven experience in the IVD or Medical Device Industries Proven experience in the maintenance and/or implementation of an ISO 13485 QMS Proven experience and knowledge of CAPA Process and Auditing Auditing certification is highly advantageous If you have the necessary skills and 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 »

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 »

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 »

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 »

organisation The Head of Quality Job, based in Milton Keynes, will require the candidate to: - Knowledge and experience in an Electronics Engineering Environment AS1900, ISO 9000, ISO 9001, ISO 13485, TS16949, ISO 14004 - Previous quality management experience and completed successful improvement projects - Experience working in more »

We are seeking a talented Regulatory Affairs Specialist to join our client's regulatory team in support of the expansion of their ISO 13485 diagnostics product pipeline. Reporting to the Regulatory Affairs Manager, you will play a crucial role in ensuring regulatory compliance and supporting the successful submission … biomedical sciences) * Two or more years of experience in regulatory affairs within the diagnostics or medical devices industry * Strong knowledge of FDA, EU regulations, ISO 13485, and ISO 14971 * Excellent communication and writing skills * Strong team-working, analytical, and problem-solving skills * Ability to make decisions and more »

Working knowledge and experience with a Quality Management System, such as deviations, investigations, CAPA, and customer complaints. · (Desirable) Experience of ISO certified QMS (ISO13485) Knowledge (Essential) In depth understanding of approaches to quality for legal manufactures · (Desirable) Knowledge of quality regulations (such as, ISO 13485, ISO more »

improvement tools and methodologies (Six Sigma, Mistake Proofing, Kaizen, etc). The Head of Quality Assurance & Testing Experience & Skills: Demonstrable knowledge and experience in ISO 9000, ISO 9001, ISO 13485, TS16949, ISO14001 previous Quality Management experience, plus having completed successful improvement projects. Experience dealing with £multi 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 »

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 »

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 »

the Head of Quality: Strong leadership and mentoring skills. Recent experience with NPI and ISO14001 Experience in Electronic Engineering Environment. 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 »

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 »

development to launch and maintenance. Manage the engineering budget to achieve product goals. Implement a robust software development process compliant with medical device regulations (ISO 13485, ISO-IEC 62304). Champion information security (ISO 27001) through design, penetration testing, and secure coding practices. Lead product management more »

as part of EMC testing when required. The candidate requires excellent written and verbal communication skills to document their activities in line with the ISO13485 Quality Management System, planning and reporting on their work to a standard suitable for review by regulatory authorities. Skills, Experience & Qualifications: Proven track record in … implementation, and validation of electronics for medical devices or other complex high integrity products. Proven track record of electronics design and development compliant with ISO 13485 and ISO 14971. Familiarity with the regulatory requirements for electrical safety for compliance with European, Canadian and United States quality standards … with practical working knowledge of IEC 60601 and ISO 13485. Experience of version control systems (Altium, PDM) for electronics design highly desirable. Ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English Enthusiasm, good communication skills and ability to work 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 »

medical equipment work or internal project work. - Produce and update procedures that are relevant to their own area of expertise to maintain the RTS ISO 9001:2015 quality management system. - Teach and train members of staff in own area of expertise. - Carry out and organise internal resource management including … fault finding, preventative maintenance & calibration principles for complex equipment. - Advanced interpretation and creation of technical documentation. Medical Equipment Management: - Advanced understanding of RTS procedures, ISO standards, and Medical Device Regulations. - Participate in on-call system for equipment management services outside of normal working hours. Clinical & Scientific Support: - Provide technical … of knowledge. Professionally registered Clinical Technologist, Clinical Scientist or HCS Practitioner Desirable Formal leadership or management training Specialist medical technical training courses Accredited UKAS ISO 9001 and UKAS ISO 13485 training courses Skills & Behaviours Essential Evidence of fault analysis, diagnosis & repair skills for complex equipment including linear 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 »

Basic software development skills Electrical analogue and digital measurements Experience with Xilinx MPsoC is a plus Experience with FPGAs is a plus. Knowledge of ISO 13485, MDD/IVDD, IEC 60601x, ISO 14971 is a plus Knowledge of Risk Management processes (DFMEA, PFMEA, AFMEA), DHF, and Tech 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 »

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 »