Senior Quality Assurance Specialist

Senior QA/RA Specialist (Hybrid – Munich Area) A leading medtech company is looking for a Senior QA/RA Specialist to support regulatory and quality activities for a portfolio of medical devices and medicinal products within a highly regulated environment. In this role, you will support local regulatory strategy implementation, and quality system activities, ensuring compliance across commercialization, distribution, and supplier management. Responsibilities Preparing and submitting regulatory documentation Acting as a key contact with local regulatory authorities Maintaining the local QMS Supporting CAPA, change control, field actions, supplier qualification and audits Ensuring readiness for internal and external audits Supporting distribution operations, product traceability and inventory activities Collaborating with cross-functional teams and third-party logistics providers Profile Bachelor’s degree in a scientific discipline 2–4 years’ experience in QA/RA within medical devices, pharma, CRO or similar regulated environment Knowledge of regulations, GMP, GDP and ISO standards Strong organisational and project coordination skills Ability to manage multiple priorities in a regulated environment Fluent in German and English #J-18808-Ljbffr