FindOut Diagnostic AB has developed a mobile application and use neural networks to take self-tests to a new level. With a drop of blood, an immunoassay lateral flow test and the app, individuals will get access to more health data than ever before. The first product with the novel technology is in the field of infection and will be launched during 2021. With the neural networks as the basis, the app will be scaled to other areas for in-vitro diagnostics.
FindOut attained its certificate for ISO 13485:2016 in 2020 and we have since had full focus and committment on ensuring our business operation, product development and manufacturing/distribution are aligned with our quality management system. Our QMS has reached a steady state and the transition from IVDD to IVDR has already been initiated to prepare for new regulations.
To achieve the current state, we have up until now had specialists consultants to ensure that the QMS is tailored to our needs and to spread awareness in the organisation. We are now at a stage where we are ready to expand our team with a Quality Assurance & Regulatory Affairs Manager, who will be responsible of ensuring the development, products and manufacturing processes are compliant with our QM. The role is part of the management team and reports to the CEO.
We see that you have an analytical mind and a keen interest in product development. FindOut is run in a start-up spirit with great ambitions, which is why it is important that you are fast-paced, driven and solution-oriented.
- Further development and maintenance of the QMS to ensure compliance with national and international regulatory standards and guidelines for the development and production of IVD and medical device software.
- Drafting and approving product development documentation to ensure compliance of regulated products (ranging from requirements for labelling, storage and packaging to upkeep of documentation and adaption to changes in directives, regulations, standards etc.).
- Drafting and approval of product documentation.
- Coordinating documentation and communicating with regulatory authorities to obtain market approval in relevant geographic regions.
- Planning, undertaking and overseeing product trials and regulatory inspections.
- Prepare for and lead FindOut in external audit execution and be responsible for internal audits.
- Quality Management Representative.
- Drive continuous improvement initiatives.
- Post-market surveillance, including vigilance for controlled products.
- Analyzing and assessing quality control and assurance data to find patterns and areas for improvements, also utilizing these data to proactively improve processes and performance.
- Keeping up to date with changes in regulatory legislation and guidelines.
- University degree in Life Science, Technology or equivalent.
- Experience in working with Medical Devices.
- Experience in Software Medical Devices is highly appreciated.
- Experience in IVDD regulation “Directive 98/79/EC”.
- Experience in ISO 13485:2016, ISO 14971:2012 and IEC 62304.
- Experience from additional quality system/ISO standards is valued.
- Minimum of 3 years of experience from Quality Assurance.
- Fluent Swedish and English, verbally and in written.
- Start: immediately
- Employment type: full time
- Location: central Stockholm
- Final application: interviews are ongoing
Does it sound exciting to develop and launch innovative medical technology products in the market and to be involved in developing a business with endless opportunities both locally and internationally? Get in touch and we’ll tell you more!
Denise Luxenburg Stuifbergen
CEO, FindOut Diagnostic AB
+ 46 (0) 768 52 44 62, Denise@findout.se