19 of 19 Remote/Hybrid ISO 13485 Jobs

help ensure that our software design and development activities meet global medical device requirements, leading the practical implementation of IEC 62304 (software lifecycle), ISO 14971 (risk management), and ISO 13485 (quality management systems) within an agile, iterative environment. You’ll help shape how design inputs, verification, validation … Medical Device Design Control Processes Lead the implementation and continuous improvement of design control processes across the software lifecycle in alignment with IEC 62304, ISO 14971, and ISO 13485. Partner with engineers and product managers to ensure requirements, risk controls, verification, and validation activities are clearly defined, documented ...

Part 11, EU Annex 11, GAMP, FDA QSR Part 820 (QMSR), EU MDR (Regulation 2017/745), IEC 62304, GDPR, ISO 13485, ISO 27001 and ISO 42001/EN 18286 regulatory & management system requirements. Essential Duties and Responsibilities: Act a subject matter expert (SME) for regulatory … Medical Device (AIaMD) validation and operation including information privacy and security requirements. Review and approve computerized system risk assessments (including as per ISO 14971& AI standards) and categorisation of software per regulatory requirements. Review and approve Computerized System Validation (CSV) packages, as an independent QA approver. Review and support ...

regulatory expertise across a broad range of client engagements, including: Quality assurance and compliance Working within and advising on Quality Management Systems compliant with ISO 13485, and QMSR . Authoring, reviewing and maintaining Design History Files, risk management file, technical documentation and change control records , ensuring alignment … process validation, equipment qualification and technical knowledge transfer, ensuring regulatory alignment throughout. Risk and post‐market activities Leading risk management activities in line with ISO 14971 , including hazard analysis, risk evaluation and mitigation strategies. Supporting post‐market surveillance, vigilance and complaints investigations , ensuring robust CAPA and documentation. Working ...

life sciences products, aerospace, automotive, or other safety-critical systems. Familiarity with medical device software development practices and applicable standards or regulations, such as: ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366 Cybersecurity guidance for connected medical devices Experience working with CDMOs, external software development ...

/EMI, signal integrity and reliable electronic design, with technical documentation and communication skills. Understanding of regulated product development and standards such as ISO 13485, ISO 14971 and IEC 60601. ...

quality control methods. Own the statistical methodology behind our algorithm, including its validation strategy. Produce statistical documentation to the standard required by our ISO 13485 quality management system. Communicate findings clearly to non-technical stakeholders, including leadership. Essential Skills & Experience MSc or PhD in statistics, biostatistics … method comparison, stability and cut-off determination. Knowledge of the CLSI guidelines, and the ability to design and defend studies against them. Knowledge of ISO 13485, with practical experience producing statistical documentation inside a quality management system. Proficiency in R, or another validated statistical environment. A track record ...

London-based role with remote working options. You will assess and improve Quality Management Systems for software-based medical devices, ensuring compliance with ISO 13485 and EU/UK MDR for QMS. The ideal candidate has 4+ years in medical device auditing, solid experience with SaMD and risk ...

Support system integration testing, coordinating test execution across hardware, firmware, and software components and documenting integration test outcomes Contribute to risk management activities under ISO 14971, including review of FMEAs and verification of risk control effectiveness Develop and maintain test infrastructure, fixtures, calibration status and tooling needed to execute … Clear and precise technical writing skills, with experience authoring test protocols and reports that meet regulatory documentation standards Nice to have: Working knowledge of ISO 14971 and ISO 13485 applied to product design and development Experience with hardware-in-the-loop or software-in-the-loop testing ...

technical stakeholders. Desirable Experience supporting software products through regulatory submissions, inspections, audits, or product approvals. Familiarity with standards and regulations such as IEC 62304, ISO 13485, FDA software guidance, EU IVDR, IEC 81001-5-1, or comparable industry frameworks. Familiarity with secure software development practices, vulnerability management, Software ...

fast-paced startup environment. Greatly Beneficial Safety-Critical Design: Experience designing for safety-critical systems or high-reliability applications-especially under standards such as ISO 26262 (automotive), IEC 61508 (industrial), or medical device standards (ISO 13485/IEC 60601/IEC 62304). Mixed-Signal Integration: Practical ...

Deep understanding of AWS services, infrastructure automation, and cloud security best practices. Background in medical imaging, life sciences, or other regulated software environments (e.g. ISO 13485, IEC 62304). Familiarity with DevOps pipelines, observability, and automated deployment at scale. Demonstrated ability to mentor junior engineers, lead code reviews ...

medical imaging analysis, clinical research tooling Machine Learning/AI development, with strong data management principles Working knowledge of frameworks such as IEC 62304, ISO 13485 Fluency in adjacent languages used across Motilent products (e.g. React/TypeScript, Java, Swagger) Experience applying advanced mathematics, geometry, optimisation, or algorithm ...

access management and continuous improvement. Develop, maintain and improve manufacturing software systems, electronic records, reporting tools and digital workflows in compliance with GMP, FDA, ISO 13485, 21 CFR Part 11 and applicable regulatory requirements. Lead Computer System Validation (CSV) activities, including the development and execution of Validation Plans ...

Requirements/What We Look For Experience in quality assurance, quality operations or quality systems within medical devices or medical technology. Working knowledge of ISO 13485, EU MDR, FDA QSR/21 CFR Part 820 and EN 62304. Experience with QMS processes, document control, SOPs, nonconformances, CAPA, change ...

multispectral, or other scientific imaging cameras, including spectral and per-band performance characterisation Experience working in a regulated industry, preferably MedTech, including familiarity with ISO 13485-compliant laboratory practice Experience working with liquid tissue phantoms, tissue-mimicking optical materials, or comparable experimental imaging targets Bonus points ...

devices or another regulated industry (e.g. aerospace, automotive safety, or similar safety-critical sectors) Working knowledge of relevant standards and regulatory frameworks, such as ISO 13485, IEC 62304, IEC 60601, or equivalent A strong grasp of the documentation, traceability, and verification rigour required for regulated, safety-critical software ...

devices or another regulated industry (e.g. aerospace, automotive safety, or similar safety-critical sectors) Working knowledge of relevant standards and regulatory frameworks, such as ISO 13485, IEC 62304, IEC 60601, or equivalent A strong grasp of the documentation, traceability, and verification rigour required for regulated, safety-critical software ...

threat assessment, vulnerability management, and secure device updates Work shoulder to shoulder with hardware, software, quality and regulatory, keeping everything traceable and compliant with ISO 13485 and IEC 62304 You’ll likely bring 5+ years delivering embedded firmware through the full product lifecycle, with a track record ...

other cancers a plus) International experience (work or study abroad) esp in North America, Europe and APAC Experience working within regulated environments (e.g. ISO 13485) What we offer Work that is both challenging and rewarding and has a real positive impact on people's lives Fast growth, ownership ...