Role: Quality Compliance Manager - Streams
Location: London, United Kingdom
Salary: Competitive salary applies
Over the past three years we’ve built a specialist team who know what it takes to deploy clinical tools in practice - engineers, clinicians, translational researchers and more. In that time, we’ve also made major advances in healthcare AI research: detecting eye disease more quickly and accurately than experts; planning cancer radiotherapy treatment in seconds rather than hours; and working to detect patient deterioration from electronic records.
Our vision is for Streams to now become an AI-powered assistant for nurses and doctors everywhere - combining the best algorithms with intuitive design, all backed up by rigorous evidence. The team working within Google, alongside brilliant colleagues from across the organisation, will help make this vision a reality.
We are looking for highly talented and driven individuals who want to be part of an exceptional team, work in an inspiring and collaborative environment, and join a company focused on ground-breaking technology with potentially extraordinary impact.
We’re a close-knit family of clinicians, product & project managers, designers, user researchers, computer scientists, ML researchers, engineers, testers and more. We’ve all made significant personal commitments to our work, and are committed to working together for the long term impact of our projects. We aim for psychological safety, dependability, empowerment, diversity & inclusion in all aspects of our work. Some of us are fresh out of university, others helped design the protocol that served you this very page. We’re looking for someone to join us, and build technology that can have a positive impact on society.
Streams seeks a Quality Compliance Manager to join our team as we ensure our adherence to regulatory standards and build on our robust Quality Management System. Streams's aim is to build AI technologies and prove that they have a positive social impact. Streams is central to this social mission. We work with hospitals on mobile tools and AI research to help get patients from test to treatment as quickly and accurately as possible.
As a Quality Compliance Manager you will lead on proactive and continuous improvements to the Quality Management System. Identify current and future project roadblocks and work with the Streams team to resolve any issues arising from them. Maintain knowledge on changing worldwide regulations and standards that are relevant to Streams.
- Support the Regulatory Manager by leading, managing and improving the quality management system for Streams software, including the training and education programme.
- Support the Regulatory Affairs Manager in preparing regulatory submissions and prepare relevant. regulatory documentation required for notifiable body registration, safety reporting and license applications.
- Ensure conformity of product in accordance with the quality management system before release and in post market surveillance.
- Ensure that existing approvals and documentation are maintained by monitoring product changes to assure quality of design, development, manufacturing, and labeling.
- Ensure that post-market surveillance obligations are met, and that the requirements for submission of vigilance reports are complied with.
- Experience Managing a QMS with Implementation of continuous improvement to Quality Management Systems for Medical Devices/ Health Technology systems. The CE marking process including management of an ISO 13485 certified Quality Management System,interactions with Notified Bodies.
- Experience of implementing standards compliance in relation to medical devices (class I, IIa and above) including compliance with the MDD, the MEDDEVs and applicable Harmonised Standards (including ISO 13485 and ISO 14971) in standalone software medical devices and devices that incorporate software (including compliance with EN IEC 62304).
- Implementation of Electronic Document management systems including computer system validation for these systems.
- Device vigilance including the reporting requirements to the MHRA and ongoing PMS.
- Supporting product development teams in collating and keeping up to date product technical documentation, regulatory documentation and declarations of conformity.
- Familiarity with the changes within the MDR including in relation to device classification, the GSPR, UDI, Vigilance/PMS, and clinical investigations. Recent experience of upgrading products through MDD to MDR.
- Qualifying degree in medicine/biomedicine or law or engineering (or other relevant scientific discipline).
- Knowledge of clinical research methodology (including clinical investigation design and biostatistics); information management; and medical writing (e.g. post-graduate experience in a relevant science or in medicine; training and experience in medical writing, systematic review and clinical data appraisal).
- Training of stakeholders from various specialties such as engineering, clinical safety, information governance in an engaging and adaptable way.
- Experience of software as a medical device, and experience working closely with software engineers. Must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues in a pragmatic way (e.g. understanding of technical development processes, system integration and deployment).
Streams welcomes applications from all sections of society. We are committed to equal employment opportunity regardless of race, religion or belief, ethnic or national origin, disability, age, citizenship, marital, domestic or civil partnership status, sexual orientation, gender identity or any other basis as protected by applicable law. If you have a disability or additional need that requires accommodation, please do not hesitate to let us know.