Waltham Abbey, Essex, South East, United Kingdom Hybrid / WFH Options
Get Staffed Online Recruitment
supporting their commitment to quality, compliance, and continuous improvement, helping to safeguard the integrity of their products and processes. Drawing on your expertise in ISO 17025 and wider regulatory frameworks, you will take ownership of their Business System Manuals and Technical Documentation, ensuring they remain robust, up to date … and audit ready. As the Management Representative for ISO13485:2016, you will lead internal audits, monitor regulatory changes, and drive compliance initiatives across the business, working closely with teams to embed quality and regulatory best practices into everything they do. Whether maintaining technical documentation, leading management reviews … of all in-vitro diagnostic medical devices manufactured and sold by our client and manage all technical documentation. To act as management representative for ISO13485:2016. Requirements for this role: Demonstrable experience of ISO 17025 accreditation within a laboratory environment. Experience of ISO 9001, ISOMore ❯
CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯
Harwell, midlands, United Kingdom Hybrid / WFH Options
OPD (Oxford Product Design)
CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯
Harwell, England, United Kingdom Hybrid / WFH Options
OPD (Oxford Product Design)
CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯
harwell, south east england, United Kingdom Hybrid / WFH Options
OPD (Oxford Product Design)
CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯
and reliable medical devices. Responsibilities: Software Development: Design and develop software for medical devices while ensuring compliance with industry standards such as IEC 62304, ISO 14971, IEC 62366, ISO13485, and FDA regulations, including cybersecurity requirements. Implementation & Compliance: Develop software solutions and support cross-functional development activities More ❯
of electronics, including the ability to read schematics and use test equipment like digital voltmeters and oscilloscopes. Familiarity with medical device regulatory standards (e.g., ISO13485, FDA guidelines) is highly preferred. More ❯
london, south east england, United Kingdom Hybrid / WFH Options
Oho Group Ltd
of electronics, including the ability to read schematics and use test equipment like digital voltmeters and oscilloscopes. Familiarity with medical device regulatory standards (e.g., ISO13485, FDA guidelines) is highly preferred. More ❯
such as PyTorch or TensorFlow. Familiarity with FDA regulatory pathways for medical software (e.g., 510(k), De Novo), and standards like IEC 62304 or ISO 13485. Experience with MLOps practices and model versioning in compliant environments. Preferred Qualifications: Experience building ML models with wearable data (e.g., continuous heart rate More ❯
and reliable medical devices. Responsibilities: Software Development: Design and develop software for medical devices while ensuring compliance with industry standards such as IEC 62304, ISO 14971, IEC 62366, IEC 13485, and FDA regulations, including cybersecurity requirements Implementation & Compliance: Develop software solutions and support cross-functional development activities, ensuring More ❯
by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001. Who we're looking for Dot Compliance is a leading provider of cloud Quality and Compliance management solutions More ❯