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.

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