Senior Quality and Regulatory Specialist
South Yorkshire, UK
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
Senior QARA Specialist - Part remote / site based at site in South Yorkshire
Permanent / Full time
Reporting to the 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. They will also be responsible for supporting activity related to legal manufacturer status. Responsible for supporting the execution of strategic QA/RA processes in line with International objectives and global strategy. The role will be a member of the QA/RA – International operations team supporting the driving of daily activities to achieve overall International team targets..
(International = all countries except USA and Canada)
- 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
- Provide supporting subject matter expertise on regulatory & quality requirements, current regulatory landscape and forthcoming regulatory changes
- Support site inspections by notified bodies
- Support training and interpretation of regulatory requirements within the International organization and other functional 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
- 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 support creation of communication materials with relevant National Regulatory authorities
- Participate in the building of strong relationships with internal and external customers to build, enhance, and ensure RA/QA awareness
- Support the identification of MDR 2017/745, IVDR 2017/746 and other International regulatory requirements for existing and future in-house/third party supplied products and coordinate/implement necessary measures in line with company commercial
We are looking for a highly self-motivated individual with exceptional attention to detail and high level skills in communication along with the following experience:
- Experienced with adverse incident reporting and vigilance processes.
- Experience of managing and hosting competent authority, notified body and customer audits.
- 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 with regulatory submissions and post market reports for device change.
- Significant experience of working in an IVD and/or Medical Device business environment in a regulatory focused position.
- Technical background with minimum Bachelor’s degree in Life Sciences or equivalent.
For further information and to apply for this role, please click APPLY