Clinical Safety Manager

Location

Remote, UK

Job Type

Company Overview

LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.

Role & Responsibilities

Clinical Safety Manager - this role can be remote based in the UK with the ability to travel to our sites in Scotland on a regular basis.  It will also involve some travel to other LumiraDx sites – both in the UK and internationally

Permanent / Full time

The Opportunity

Clinical safety of our products is of paramount importance to the company and the Clinical Safety Manager will lead the global Clinical Safety Management activities across the company. Reporting to the Medical Director, and leading the Clinical Safety Officers and Clinical Safety teams, the role is responsible for encouraging and supporting a culture of clinical safety and ensuring compliance with relevant national and international clinical safety standards across the company.

The Role

  • Take ownership of the Clinical Safety Management processes/documentation across the global company
  • Regularly review and update the Clinical Safety Management policies and protocols
  • Lead the Clinical Safety Teams and organise regular and ad-hoc meetings to review clinical safety aspects of the company’s products and services and in response to customer feedback/complaints
  • Liaise regularly with Product Owners / Product Managers during product development to provide clinical risk assessment/ safety management input
  • Provide line-management to the Clinical Safety Officers
  • Supervise / review the clinical risk assessment activities of the company’s Clinical Safety Officers and its associated documentation
  • Liaise with the RA/QA departments over clinical safety issues and risk assessment
  • Liaise with the Clinical and Medical Affairs departments over clinical safety/ risk management issues
  • Oversee the training and development of the Clinical Safety Officers
  • Participate in the product /software releases with reference to clinical safety
  • Participate in team reviews, retrospective discussions and appraisal
  • Actively engage in continuous development of your skills
  • Maintain personal accreditation in Clinical Safety Management with relevant national organisations (eg NHS Digital)

Required Experience

About You:

We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in communication and leadership, along with the following skills and experience:

  • Experience of Clinical Safety Management / Clinical Risk Assessment and its application in clinical settings (eg hospital, primary care) in a Medical Device/ IVD or Health-related software environment
  • Understanding of the application of clinical risk management methods across the entire Software Development Lifecycle -especially Agile methodology.
  • Understanding of Clinical Safety regulatory requirements for a relevant health organisation (eg DCB1029) as well as relevant standards (eg ISO14971), and MDR / IVDR regulations
  • Understanding of Clinical Safety/ Risk management requirements and processes outside UK – especially US/ EU
  • First-hand experience of being involved in MD/IVD / QMS Audits (eg ISO13485)
  • Up-to-date training and accreditation in Clinical Safety Management

 

For further information and to apply for this role, please click APPLY

APPLY

Thank you for your interest. If you're successful in your application, you may be subject to all or some of the LumiraDx standard pre-employment checks. This includes employment references; Criminal records data checks which are processed as part of our recruitment process for employment or continued employment to comply with legal and regulatory obligations to which the company is subject. LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security.