Are you an experienced QA/RA specialist with experience from the medical industry? And are you looking for a new opportunity to advance your skills and help diagnose brain diseases such as Alzheimer’s? Then come and join the ambitious Brainreader team!

The Neuroreader® software from Brainreader is changing the way Alzheimer’s and other neurodegenerative diseases are diagnosed with the help of patented software solutions. You will be part of a dedicated development team with a vision to provide cutting-edge clinical solutions-based healthcare for everyone.

Take ownership of quality of design, standards, and compliance

Your main responsibility will be to perform QA/RA in accordance with ISO 13485, MDR and FDA. You will work closely together with the development team, management team and sales team based in the US to ensure compliance with the set procedures.

Brainreader has an FDA cleared, CE marked (MDD) and ISO certified product. They are working on the MDR transition.

Your tasks will be highly diversified and will include the generation of product development procedures and the development of the Quality Management System processes.

Your responsibilities on a day to day basis will include:

• Implementation and maintenance of QMS

• Proactively engaging with the organization to ensure effective compliance to set procedure and regulations

• Providing compliance to IEC 62304 for medical software.

• Providing support to MDR Regulation (EU) 2017/745 transition, by using harmonized standards and regulations.

• Organization of competence and awareness training and focus on quality and regulations.

• Conducting Internal and Supplier Audits, Participating in External Audits.

• Participating in developing the core processes, including development procedures, internal and external audits, etc.

• Generating Quality and Development documentation to support our future 510(k) submission.

• Initiation and monitoring of CAPA process.

• QA release of finished Products.

• Close collaboration with internal and external stakeholders to support compliance and quality according to FDA CFR Part 8.20.

Background requirements

You have at least 2 years of experience in medical and regulatory support, and you have an educational background in engineering or another similar technical background. Most importantly, you have the skills to drive the QA/RA development processes, and the experience to recommend, implement, and execute process improvements of QA/RA.

You bring your expertise into play by asking the right questions, clarify assumptions, ensure compliance and work together with the software development team. As a person, you take ownership, you’re analytical and you welcome new and exciting challenges. You are not only a strong team player who is motivated by the success of the business, but also a self-starter committed to making things happen.

About Brainreader and the purposeful journey ahead

Brainreader is one of the most exciting MedTech companies in Denmark thanks to the Neuroreader® software, an assessment tool for healthcare professionals. Neuroreader® helps improve the lives of patients with brain disorders by assisting the medical staff in discovering otherwise overlooked diseases and ensuring quick and correct medical treatment to patients. Through its work, Brainreader aims to provide quantifiable and accurate insight into the brain.

The Brainreader team is located in Copenhagen, Frederiksberg, and in the US, and is currently around 15 people. Brainreader is growing rapidly, so you will be joined by many new colleagues in 2022. This is an exciting time to join where you will have a huge influence on the future of Brainreader.

We only accept applicants that do not require relocation.

Work place: Hybrid (Frederiksberg and remote).

Interviews will be conducted at a continuous basis.