Senior SaMD QARA Consultant

Direct message the job poster from SciPro Principal Specialist Consultant at Scipro – Medical Devices & Digital Health across DACH Scipro seeking an experienced Senior QARA Consultant specializing in Software as a Medical Device (SaMD) for a specialist life sciences consultancy in Switzerland. This role will focus on guiding clients through regulatory challenges and quality management for medical software products, from development through post-market activities. Key Responsibilities Develop regulatory strategies for SaMD, including preparing 510(k), De Novo, CE Marking, and international submissions. Implement and maintain QMS processes aligned with standards such as ISO 13485, IEC 62304, and FDA QSR. Lead risk management activities according to ISO 14971 and IEC 62304, working with teams to integrate risk, cybersecurity, and validation. Oversee technical documentation, clinical evaluations, and post-market surveillance. Provide strategic regulatory and quality advice to clients, keeping them informed on regulatory updates and best practices. Requirements Experience: 7+ years in QARA roles within the medical device or SaMD field, including 3+ years in SaMD-focused work. Bachelor\’s or Master\’s in Biomedical Engineering, Regulatory Affairs, Quality Management, or related field. Deep understanding of FDA, EU MDR, ISO 13485, IEC 62304, and ISO 14971 standards; familiarity with software lifecycle and cybersecurity as they apply to SaMD. Scipro is acting on behalf of this company. Please apply now or send your CV to to arrange a confidential conversation. Seniority level Mid-Senior level Employment type Full-time Job function Quality Assurance Industries Medical Equipment Manufacturing #J-18808-Ljbffr