Job Overview:
The QM/RA Specialist will play a pivotal role in ensuring compliance with regulatory requirements
and maintaining the highest quality standards for mainly Class 3 medical devices (Orthopaedics,
Implants). This position requires a minimum of 2 years of experience, with a strong preference for
candidates with prior experience in Class 3 medical devices. The role is hybrid, requiring the
incumbent to be on-site in Hurth 2-3 times a week (for the first 6 months – after that period of time
Remote working is an option).
Key Responsibilities:
• Ensure Regulatory Compliance (ISO 13485, MDR)
• Manage Document Compliance and Accessibility
• Oversee Quality Control Processes
• Implement and Manage Risk Mitigation
• Prepare and Submit Regulatory Documents
• Coordinate Audits and Inspections
• Drive Continuous Improvement
• Collaborate with Cross-Functional Teams (Quality, Regulatory, Clinical Affairs and R&D
departments)
Qualifications:
• 2+ years of quality management and regulatory affairs experience, preferably with Class 3
medical devices.
• Proficient in ISO 13485 and EU MDR.
• Experience in regulatory submissions and approvals.
• Strong organizational and document management skills.
• Excellent communication and interpersonal abilities.
• Capable of working independently and collaboratively.
• Proficiency in both English and German.