Alex Therapeutics is a Stockholm-based Medtech startup that develops digital therapies (DTx). We create and deliver accessible, evidence-based treatments through smartphone apps. By combining evidence-based psychology with leading design and technology we’re able to develop digital medicine products that help under-treated patients all across the world. Located in central Stockholm, our team is seeking to fundamentally change the way modern healthcare works.

Role Description

As QA/RA Engineer you will be the interface between the development and regulation of software-as-a-medical-device (SaMD) products. You will support and contribute to development of safe and effective products, as well as an efficient quality management system, in a lean and agile start-up environment that simultaneously ensures regulatory compliance whilst allowing for the fast development of new innovative products.

Qualifications (need-to-haves)

• University degree in a relevant subject with a focus on analytical thinking and precise, reliable working methods
• Medical Device / Software background
• Experience/knowledge of working with quality management systems
• Familiar with standards and regulations in the field of medical devices (e.g. ISO 13485, EU Medical Device Regulation (MDR) and US Quality Systems Regulation (QSR)), and enjoyment in applying and deepening this knowledge.
• Familiarity with basic software design and development procedures
• Works well independently
• Fluency in English

Nice-to-haves

• A high interest in software development and testing, ideally basic experiences in programming
• Experience of working with Quality Assurance of software, in particular SaMD
• Experience from performing software risk management, particular in accordance with ISO 14971 and IEC 62304 and enjoyment in applying and deepening this knowledge.
• Interest in documentation
• Well organized and structured in their work
• Fluency in Swedish, German

Job Description

• Contribute to implementation, further development and maintenance of our Quality Management Systems, assuring regulatory compliance in alignment with business activities and process efficiency
• Establish and maintain technical documentation for our SaMDs
• Participate/lead design control activities in product development projects
• Participate/lead in product risk management
• Create, review, approve and manage documentation
• Track and implement new regulatory requirements in the QMS and product development
• Develop design and development processes that comply with the regulations for technical documentation whilst simultaneously allowing for agile software development
• Perform internal audits and participate in external auditors
• Assist with regulatory submissions

Details

• Full-time position
• Part-flexible location with the Alex Therapeutics office located at Upplandsgatan 7, Stockholm
• 5 weeks paid vacation, pension and wellness benefits
• Reporting to the Chief Quality and Regulatory Officer (CQRO)

Working at Alex

• Doing good – we're all about creating positive impact
• Work on a growing product portfolio improving mental health
• Learn and develop in an fast paced startup environment
• Play an important part in shaping the future of Alex
• Opportunity to join a fun, passionate and energetic team
• Centrally located office in Stockholm, Sweden with opportunity to work partly remote