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