6 ISO 13485 Jobs in Oxford

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 »

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 »

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 »