YOUR PROFILE:

• Completed degree in medical engineering, life sciences, or a comparable field Initial practical experience or internships in the field of Regulatory Affairs is an advantage
• Basic understanding of relevant regulatory frameworks (e.g., MDR 2017/745, ISO 13485, MDSAP) is a plus
• Structured, detail-oriented, and eager to learn
• Excellent written and spoken German and English skills
  Job Types: Full-time, Permanent

Education:

• Bachelor’s (Preferred)

Language:

• German (Required)

• Support in the planning, coordination, and follow-up of international registrations for medical devices
• Assist in ensuring compliance with regulatory requirements according to MDR, MDSAP, and ISO 13485
• Contribute to the preparation and maintenance of technical documentation for global registrations
• Help compile and organize documentation for license renewals, updates, and new submissions
• Communicate with international partners, authorities, and internal departments in alignment with the Regulatory Affairs team