QARA Specialist International
Remote, UK or Europe
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
QARA Specialist - International - Remote based in the UK or Europe
Permanent / Full time
Reporting to LumiraDx Senior QA/RA Manager - International, the QA/RA Specialist is responsible for supporting the initiation, timely achievement, and maintenance of product registrations, supporting partial QMS responsibility for post market distribution, complaints, and product vigilance/recall.
Responsible for supporting the execution of strategic QA/RA processes in line with International objectives/Global strategy. S/He will be a member of the QA/RA – International operations team, supporting the driving of daily activities to achieve overall International team targets. Supports the team to help drive the mission of LumiraDx utilizing collaboration and a balanced approach.
(International = all countries except USA and Canada)
- Provide supporting subject matter expertise on regulatory/quality requirements, current regulatory landscape, and forthcoming regulatory changes
- Support training and interpretation of regulatory requirements within the International organization and other functional LDx teams as needed
- Ensure the preparation of high quality, ready first time, filings and registrations and support responses to Authorities and internal requests within established timelines (excluding Tech file or equivalent document creation and updates – responsibility of site Legal Manufacturers)
- Support regulatory change controls and re-registrations, including relevant NTFs (Notes to File), pre or post notification of significant change as required
- Support regulatory responsibility for post market activities including distribution and provide support to ensure that regions follow the appropriate post market surveillance, complaints, adverse incident reporting and vigilance processes.
- Facilitate and support the process of product recall
- Support the review of regulatory submissions and promotional materials for compliance with International regulations
- Actively participate in process improvement, harmonization, and simplification efforts to lead and advance continuous improvement culture
- Build strong relationships with internal and external customers to build, enhance, and ensure RA/QA awareness
We are looking for a highly motivated individual with exceptional attention to detail along with the following experience:
- Knowledge and experience of working to the applicable quality standards and regulatory requirements of more than one international jurisdiction (all countries except USA and Canada)
- Experience of working in an IVD and/or Medical Device business environment with minimum 3 years’ experience
- Technical background with minimum Bachelor’s degree in Life Sciences or equivalent
- Ability to use data, problem solving tools and methodologies to drive innovative solutions
- Ability to take a risk-based approach to prioritization and decision making
- A team player, able to work with and influence others at all levels
- Good interpersonal skills, with an ability to maintain the credibility of the International team (internal and external)
- Good presentation and communication skills
- Knowledge and experience in instrument based IVD platforms
- Experience working within a dynamic and fast paced start-up environment
For further information and to apply for this role, please click APPLY