Regulatory Affairs Specialist

Job Summary

A company is looking for a Senior Specialist, Regulatory Affairs.

Key Responsibilities

• Support regulatory submissions and maintenance of technical files for in vitro diagnostic devices
• Develop documents for clinical performance studies and support clinical trial applications
• Provide regulatory guidance on global requirements throughout product development

Required Qualifications

• Minimum 5 years of industry experience
• Bachelor's or Master's degree in a related field
• Experience with EU conformity assessments and clinical performance studies under IVDR
• Familiarity with international standards such as ISO 13485 and IEC 62304
• Experience with next generation sequencing in vitro diagnostics in regulated environments