Director - Design Quality and Regulatory
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
Director - Design Quality and Regulatory - Site based at our site in Glasgow
Permanent / Full time
This role will be responsible for leading regulatory and design quality (design assurance) for products manufactured at the LumiraDx Glasgow site. Leadership role with responsibility for providing strong expertise and direction for design quality and regulatory for IVD assays, including molecular diagnostics.
Will work collaboratively with internal and external R&D and design transfer teams. Reporting to the VP Global QARA, this role will also work collaboratively with the Glasgow-based VP Research and Development.
- Provision of expertise and experience for project teams throughout new product lifecycle to ensure applicable standards and regulations for the products being brought to the market are
incorporated throughout the development lifecycle.
- Leadership of an integrated approach to design assurance, regulatory and design to meet customer needs and regulatory requirements.
- High level of project, people, and technical collaboration across LumiraDx global sites.
- Responsible for driving the development of product-specific regulatory pathway plans in collaboration with regional regulatory teams. Integrates global feedback into consolidated strategies and plans.
- Responsible for implementing sustainable process relating to creation and maintenance of Technical Files and Design History Files in accordance with IVDR.
- Leads regulatory aspects of new product design and development processes.
- Collaborate in the writing of design requirements and specifications, Verification and Validation plans and protocols, and design transfer plans.
- Support risk management related activities and design reviews with the project teams and ensure compliance of such activities to the applicable standards and regulations.
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:
- Relevant Regulatory and Quality experience with IVD
- Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21 CFR Part 820, and Design Controls guidance documents
- Bachelors degree in relevant discipline. Advanced degree in a medical, science or technical discipline would be preferred
For further information and to apply for this role, please click APPLY