Regulatory Affairs Manager
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
Regulatory Affairs Manager - Diagnostics Post Launch
This is a multi-site role and can be based at any of our sites in Central Scotland - Alloa, Glasgow and Bathgate - will be required to travel across these sites as well as some UK and possibly international travel
Full time - Permanent
Reporting to the LumiraDx Diagnostics QMS Director, the successful candidate shall be responsible for the post launch regulatory activities for the legal manufactured products associated with IVD medical devices (assays, instruments, software and ancillary items relating to the system) for the LumiraDx Diagnostics Business.
The role encompasses all post launch regulatory activities, including (but not limited to):
- Management of relationship and ISO13485 QMS certificate and scope with relevant certification/notified body,
- Interface between legal manufacturer and International RA for regulatory assessments related to product and QMS changes, PMS and market vigilance activities,
- Maintenance of regulatory compliance status of the legal manufacturer QMS in consideration of global regulatory requirements.
- Manage relationship with applicable certification and notified bodies.
- Maintain site ISO13485 certificate.
- Provide inputs to and collaborate with International RA on any post launch change plans.
- Provide regulatory support in the development and maintenance of the QMS in consideration of upcoming regulatory changes.
- Lead and manage a team of Regulatory Specialists working in post launch regulatory, including day to day activities to support the business in accordance with ongoing product commercialisation plans.
- Provide regulatory intelligence and expertise as required by the business and within own area of responsibility.
- Support the training and development needs of the team
- Provide training for other areas of the business on regulatory process and other compliance activities.
We are looking for a highly self-motivated individual with exceptional attention to detail and high level skills in leadership along with the following 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 Clinical processes
- Experience and knowledge of vertical and horizontal standards for IVD medical device instruments, software and assays in the point of care.
- Previous experience in people management
- Excellent organizational skills
- Demonstration of good problem solving abilities
- Strong communicator
- 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
For further information and to apply for this role, please click APPLY