Clinical Safety Manager

Location

Scotland, UK

Job Type

Permanent

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 Central Belt of Scotland with the ability to travel to our site in Stirling.  It may also involve some global travel

Permanent / Full time

The Opportunity

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

The Role

  • Take ownership of the Clinical Safety Management processes/documentation across the company
  • Regularly review and update the Clinical Safety Management policies and protocols
  • Lead the Clinical Safety Team 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
  • Oversee the training and development of the Clinical Safety Officers
  • Participate in the authorisation processes for 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 registration with your professional body

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:

  • Previous experience as a Health Care Professional.
  • Experience of Clinical Safety Management / Clinical Risk Assessment and its application in clinical settings (eg hospital, primary care) – ideally in a Medical Device/ IVD or Health-related software environment
  • Understanding of Clinical Safety regulatory requirements for a relevant health organisation (eg NHS) as well as ISO and IVDR regulations
  • First-hand experience of being involved in MD / ISO Audits
  • Experience of different Clinical Risk Assessment techniques, management, and documentation in Agile working as well as standard waterfall techniques
  • Current registration with an appropriate professional body
  • Up-to-date training and accreditation in Clinical Safety Management
  • Must be an experienced, qualified registered healthcare professional (clinician) an accredited Clinical Safety Officer

 

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.