Regulatory Affairs Specialist

Regulatory Affairs · Manor Loan, Stirling
Department Regulatory Affairs
Employment Type Permanent
Minimum Experience Experienced
Compensation Competitive

Regulatory Affairs Specialist - this role will be based at our site in Stirling with some home/remote working 


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.

 

The Opportunity

Reporting to the LumiraDx  Regulatory Manager, the successful candidate shall be responsible for the regulatory activities for the legal manufactured products associated with  IVD medical devices (assays, instruments, software and ancillary items relating to the system) development through the R&D 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.


The Role

  • Creation and management of technical files of all legal manufactured products
  • Creation of QA/RA 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
  • QMS updates required for higher risk IVD’s such as PMA and WHO 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


About You


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


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

 

At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business


Please note, if you wish to submit an application for this role, please consider the following information

This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.

Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable 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. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.

Thank You

Your application was submitted successfully.

  • Location
    Manor Loan, Stirling
  • Department
    Regulatory Affairs
  • Employment Type
    Permanent
  • Minimum Experience
    Experienced
  • Compensation
    Competitive