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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. Key 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