10 ISO 13485 Jobs in Oxfordshire

leadership skills and a desire to drive continuous improvement in quality processes. Key Responsibilities 1. Develop, implement, and maintain the QMS in accordance with ISO 9001, ISO 13485, UK MDR 2002 & (EU) MDR 2017/745. 2. Ensure compliance with applicable regulations and standards, including FDA regulations … years of experience in quality management within the medical device industry. Experience with implementing and maintaining Quality Management Systems (QMS) in accordance with ISO standards. · Knowledge of ISO Standards including ISO 13485, ISO 9001, ISO 14971, IEC 62304 and EN 60601. · Knowledge of global 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 »

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 »

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 »

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 »

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 »

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 »

Experience operating in ISO9001 environment Excellent working knowledge of document management systems, change control and CAPA systems Knowledge and experience of working in an ISO13485 environment is advantageous Good team player and able to work in a fast-paced environment with minimal supervision Keywords: Quality Assurance Specialist, QA Specialist, Regulatory … Specialist, Quality Assurance Manager, QA Manager, ISO9001, ISO 13485 Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency 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 »