Regulatory Affairs Manager, Health

London, United Kingdom

Role: Regulatory Affairs and Quality Manager

Location: London, UK

Salary: Competitive salary applies

 DeepMind - Applied

 DeepMind’s Applied Group focuses on using the best available technologies, together with our own research, to address some of the world’s most pressing and complex challenges. We work in fields from healthcare to energy efficiency, collaborating with experts to build tools to support and improve their work.  Collaborating with multiple teams, we also apply our cutting edge research to products used by many people around the world. These real world applications of AI technology help us work towards one of DeepMind’s purposes - to use intelligence to make the world a better place.

 The Team

 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.

 The Role

 DeepMind Health seeks a Regulatory Affairs/Quality Manager to join our team as we ensure our adherence to regulatory standards. DeepMind's aim is to build AI technologies and prove that they could have positive social impact. DeepMind Health 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.

 Responsibilities 

  • Develop strategies and submissions for complex products to gain approvals for commercial distribution and clinical research in various geographies.
  • Work with the DMH team to develop world-class approaches to clinical trials and evaluation, providing guidance and support including design verification, pre-clinical, and clinical studies.
  • Improve, lead and manage a quality management system for DMH software, including training and education.
  • Lead and prepare relevant regulatory documentations required for notifiable body registration (MHRA, FDA etc) and license applications
  • Ensure conformity of product in accordance with the quality management system before release.
  • Ensure that regulatory submissions are prepared.
  • 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 requirements for submission of vigilance reports are complied with.
  • Act as liaison between Clinical, Regulatory, Research, Partner, Trial Unit, Engineering, Product, Design and Legal Teams
  • Identify current and future project roadblocks and work with the team to resolve any issues arising from them
  • Lead proactive and continuous improvements for Regulatory Affairs and in support of the quality system
  • Maintain knowledge on changing worldwide regulations and standards that are relevant to DeepMind Health
  • Communicate status updates, issues and potential issues regarding regulations and standards to key stakeholders

 

 About you

 Experience:

  • Leading regulatory  affairs and quality standards compliance  experience in relation to medical devices (class I, IIa and above) including compliance with the MDD, the MEDDEV 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).
  • Providing advice to teams conducting clinical evaluations and clinical investigations in accordance with the MDD, MEDDEV and ISO 14155:2011.
  • The CE marking process including implementation of an ISO certified Quality Management System and interactions with Notified Bodies and the MHRA.
  • 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.
  • Understanding of and familiarity with the changes within the MDR including in relation to device classification, the GSPR, UDI, Vigilance/PMS, and clinical investigations.
  • Suitability for the role of the Person Responsible for Regulatory Compliance under the MDR

Minimum Qualifications:

  • Qualifying degree in medicine/biomedicine or law or engineering (or other relevant scientific discipline).
  • Equivalent of 5 years experience in regulatory aspects of medical devices and quality management for digital health software, should include experience with FDA (21 CFR Part 820, 812, 807), ISO 13485, CE Marking, Class I/II/III medical devices)
  • Technically competent and must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues ( e.g. understanding of technical development processes, system integration and deployment). Ideally with experience of software as a medical device, and experience working closely with software engineers. 

Desirable:

  • 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).

  

DeepMind 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.

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