Regulatory Affairs Specialist

Location

Manor Loan, Stirling

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

Opportunity:

Reporting to the LumiraDx Quality and Regulatory Director, the successful candidate shall be responsible for the regulatory activities for the legal manufactured products associated with In Vitro Diagnostic medical devices (assays, instruments, software and ancillary items relating to the system) development through the Research and Development phase and the verification and validation phase through launch and post marketing arena.
Activities such as requirements generation document/process creation, review and approval of documents and working with all project teams to guide the teams in the day to day development  and to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the development.
Key Roles and Responsibilities:
  • Creation and management of technical files of all legal manufactured products
  • Creation of Quality Assurance/Regulatory Affairs plans for the design and development teams to support Global markets up to the formation of the standard dossier.
  • Creation and maintenance of harmonized standards compliance plans
  • Quality Management System updates required for higher risk In Vitro Diagnostics such as Premarket Approval and World Health Organisation pre-qualification programme activities.
  • Review and approval of change requests for regulatory impact assessment
  • Creation of process for the management of approval of global marketing collaterals and localization process
  • Review and approval of marketing collaterals

Required Experience

Essential skills:
  • Knowledge and experience of working to the appropriate quality and regulatory standards including ISO 13485, ISO 14971, FDA 21CFR part 820, IVD 98/79/EEC/IVDR
  • Development and writing of CE marking technical files
  • Knowledge of Adverse event reporting in clinical environment
  • Detailed knowledge of post market regulatory activities including Field Safety Corrective Actions, incident reporting
  • Experience and knowledge of vertical and horizontal standards for IVD medical device instruments and assays in the point of care.
  • Experience of working in an In Vitro Diagnostic or medical device design and manufacturing environment
  • Strong communicator.
  • Excellent organizational skills
  • Demonstration of good problem solving abilities.
  • Influence internal project team and external parties to maximize success opportunities.

 

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

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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.