Quality & Regulatory Affairs Expert

We are looking for a Quality & Regulatory Affairs Expert to support our team in the creation and maintenance of technical documentation and to gain hands-on experience in the development, verification, and regulatory compliance of medical devices under the EU MDR.

This role is ideal for early-career professionals who want to grow into a regulatory and product-focused role within medical devices.

Key Responsibilities

• Support the preparation and maintenance of Technical Documentation according to EU MDR (2017/745)
• Assisting, creating and updating:
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• Risk Management documentation (ISO 14971)
• Usability Engineering documentation (IEC 62366)
• Clinical Evaluation documents (CER) under guidance
• GSPR checklists and compliance matrices

• Support product development, verification and validation activities
• Help manage documentation during design changes
• Preparations for audits and Notified Body interactions
• Collaborate with R&D, Quality, Clinical and external partners

Your Profile

• University degree in Pharmacy, Chemistry, Biochemistry, Technology or similar preferred
• 1–3 years of experience in Quality Assurance and/or Regulatory Affairs within a pharmaceutical or related regulated industry
• Basic knowledge of EU MDR and medical device standards (ISO 13485, ISO 14971, IEC 62366)
• Structured, detail-oriented and motivated to learn
• Good communication skills and a proactive mindset
• Fluent in English (German is an advantage)

What We Offer

• Structured onboarding and continuous learning
• Opportunity to grow into a senior QA/RA role
• Stable position in a specialized healthcare sector
• Supportive and professional working environment