Title:  Quality Assurance Manager

Your main tasks

• Prepare, support the creation and review and execute the release of all technical documentation for digital health and software products ensuring compliance with applicable standards and regulatory requirements such as IEC 62304, IEC 82304-1
• Ensure regulatory compliance of digital health technologies, including cloud platforms, software development kits for mobile applications (SDKs), embedded software, and mobile applications
• Ensure effective change control activities during the entire product life cycle
• Ensure validation of tools and computer systems in compliance with ISO 80002-2 and AAMI TIR36, maintaining appropriate documentation and traceability
• Ensure compliance with interoperability regulations and standards by overseeing documentation, risk management, and quality assurance activities related to software interfaces, following ANSI/AAMI/UL 2800 series
• Work independently and support the teams in Burgdorf/Switzerland and Barcelona/Spain
• Ensure that secure software development practices are linked to risk management activities and reflected in the product documentation
• Support the documentation of data protection and electronic records compliance (GDPR, HIPAA, 21 CFR Part 11) throughout the product lifecycle.
• Support and strengthen software risk management activities by ensuring full traceability and alignment between ISO 14971 and IEC 62304 requirements, emphasizing continuous risk evaluation throughout the lifecycle

Your profile

• Bachelor’s degree in computer science, software engineering or another relevant scientific discipline, or equivalent combination of education and years of applicable experience
• 5 years of professional experience in software quality assurance or regulatory affairs related to medical devices, with a focus on software as a medical device (SaMD) preferred
• Experience in the implementation of the process and tools to develop software according to IEC 62304
• Experience with software validation, cybersecurity, data protection and artificial intelligence
• Proven experience in preparing and submitting regulatory filings, managing regulatory interactions, and facilitating successful product approvals
• Outstanding communication skills, with the ability to collaborate effectively with cross-functional teams
• In-depth knowledge of quality management systems (QMS) standards (e.g., ISO 13485 and MDSAP), medical device regulations (e.g. FDA, EU MDR, UK MDR, Health Canada), and software development lifecycle methodologies
• Strong understanding of risk management principles, design controls, verification and validation processes, post-market surveillance and vigilance requirements for medical devices including software development standards (e.g. IEC 62304, IEC 62366)
• Written and spoken English