Beschreibung

In this role, you will enhance Regulatory Affairs and quality management systems while coordinating international approvals for medical devices. Your day-to-day responsibilities will include preparing technical documentation, supporting compliance efforts, and conducting audits.

Anforderungen

• •Degree in natural sciences, biomedical engineering, or comparable qualification
• •Experience in the medical device industry, ideally in validation of sterilization processes (ETO)
• •Familiarity with regulatory requirements for medical devices in the EU (EU MDR, ISO standards, MPDG); knowledge of pharmaceutical regulations (AMG, GMP) and international standards (US FDA) advantageous
• •Good understanding of medical devices and functional pharmaceutical coatings
• •Independence, structured work, and teamwork skills
• •Proficiency in MS Office, Adobe Acrobat, and quality management systems according to EN ISO 13485
• •Excellent written and spoken German and English skills

Aufgaben

• •Develop Regulatory Affairs and quality management systems
• •Coordinate international approval and registration for medical devices
• •Prepare and maintain technical documentation
• •Communicate with customers, suppliers, and authorities worldwide
• •Handle inquiries from regulatory authorities
• •Research country-specific approval requirements
• •Support R&D, production, and logistics with regulatory compliance
• •Maintain change management processes
• •Support design and process changes
• •Prepare and conduct audits
• •Communicate with customers and authorities during audits

Tools & Technologien