Stockholm, Stockholm County, Sweden
Quality Manager, Person Responsible for Regulatory Compliance (PRRC), and Data Protection Officer (DPO) at Platform24 Healthcare AB, a SaaS MedTech company delivering AI-powered digital health solutions. I lead quality and compliance operations across EU MDR, ISO 13485, ISO 14971, and GDPR — managing a team of technical writers, quality specialists, and regulatory consultants, reporting to the Chief Medical Officer. My day-to-day spans QMS operations, regulatory strategy, risk management, CAPA processes, internal audits, and technical documentation for Software as a Medical Device (SaMD). Current focus areas: → EU MDR compliance strategy for AI-based medical devices, including regulatory strategy → Building AI-assisted quality management workflows that embed compliance into development rather than treating it as overhead → Modernizing technical documentation and eQMS processes → GDPR compliance for cloud-based healthcare platforms processing sensitive patient data Background in engineering (MSc Medical Engineering, KTH) with hands-on experience in programming, databases, and automation — bridging the gap between regulatory requirements and practical technical implementation. Former member of SIS/TK355, the Swedish technical committee for risk and quality management in medical devices, contributing to the development of standards used across the industry. Previously worked in Medical Device QA/RA consulting and project management. Always happy to connect on EU MDR, SaMD regulation, AI in MedTech, quality management, or digital health.