Regulatory Affairs Manager
San Diego, US
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 organization. We have recently launched the innovative LumiraDx Platform and fast lab solutions, 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
Reporting to LumiraDx’s Global VP of Quality & Regulatory, the Regulatory Affairs Manager (San Diego, CA) provides professional regulatory guidance and support for the LumiraDx molecular diagnostics and protein reagent business located in Solana Beach, CA and San Diego, CA. They will undertake activities such as document / process creation and review and approval of documents. A key responsibility will be working closely with and guiding project teams in the day-to-day development of products being brought to the market ensuring applicable standards and regulations are incorporated throughout the development.
Key Roles and Responsibilities
- Management or regulatory dossiers of all legal manufactured products for pre and post-market
- Management and 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
- Creation and maintenance of regulatory procedures to align with Global requirements
- 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
- Management of regulatory process relating to marketing collaterals and country localization process
- Review and approval of Labelling and marketing collaterals
- Lead and manage a team of Regulatory Specialists working in pre and post market environment, including day to day activities to support the business in accordance with pipeline plans and non routine activities as required by the business.
- 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 motivated individual with exceptional attention to detail and high level of skills in problem solving and 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 process
- 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