Specialist Quality Management & Regulatory Affairs (m/w/d)

We are looking for an experienced Specialist in the field of Quality Management and Regulatory Affairs (m/w/d) for our customer, a future-oriented company in the medical technology sector.

Your Tasks

• Development and maintenance of a quality management system according to ISO 13485 and MDSAP
• Coordination and implementation of internal and external audits, as well as accompaniment of certification processes
• Processing of complaints and conducting root cause analyses
• Preparation, maintenance, and administration of technical documentation according to MDR
• Contact person for regulatory questions and authorities
• Documented and analyzed quality key figures for process improvement
• Compilation of registration documents and management of international registration projects

Your Profile

• Bachelor's degree in engineering, medical technology, quality management or a comparable qualification
• Multiple years of experience in quality management and regulatory affairs, ideally in the medical technology sector
• In-depth knowledge of ISO 13485 and regulatory requirements (e.g. MDR, MDSAP)
• Structured, independent, and reliable working style
• Outstanding analytical thinking and hands-on mentality
• Excellent communication and presentation skills in German and English

Your Benefits

• Hanse-Fit offer
• Flexible working time models and modern workspaces
• Inclusive company pension scheme and health promotion
• Active further education and training program
• Much more!