Descripción
Do you have experience in Quality & Regulatory within Software as a Medical Device and enjoy working at the intersection of product development, quality, and regulatory requirements? Are you technically curious and experienced in supporting development teams through complex changes? Then the role as Senior Quality & Regulatory Specialist at Qbtech could be the right opportunity for you! About Qbtech Qbtech is an international MedTech company developing technology-based solutions for the assessment and monitoring of ADHD. Founded in 2002, Qbtech operates across several international markets, with offices in Stockholm, London, and Houston. Qbtech’s solutions are used by clinics worldwide, with a mission to contribute to more accessible, efficient, and data-driven ADHD care. About the role As Senior Quality & Regulatory Specialist, you will act as an important link between Qbtech’s Product and Software teams and the QA/RA function. You will support Product Owners and development teams in product changes, releases, and design changes, ensuring that quality, risk management, and regulatory requirements are integrated throughout the software lifecycle. The role also includes working with technical documentation, Medical Device Files, regulatory assessments, and market expansion activities. A particular focus will be on the implementation and continuous development of Qbtech’s eQMS, as well as the validation of digital systems and tools. Your main responsibilities: Support Product and Software teams with change management, releases, and risk assessments. Ensure Quality and Regulatory requirements are integrated into product development. Review and maintain technical documentation and Medical Device Files. Contribute to regulatory assessments, submissions, and market expansion activities. Implement and further develop Qbtech’s eQMS. Support the organisation with risk management, audits, and training. About you You have several years of experience within Quality & Regulatory