Quality & Regulatory Affairs (QRA) Specialist (FT - Remote Europe)

Ikerian AG is seeking a meticulous QRA Specialist to strengthen their quality and regulatory operations team. The role involves ensuring product compliance, supporting regulatory filings, and maintaining a robust quality management system. They are a fast-growing medical device software company focused on enabling faster and safer healthcare decisions through AI and data management.

Requirements

• Ensure product compliance with FDA, EU MDR, ISO 13485, IEC 62304, and other applicable standards.
• Review internal procedures for compliance with global regulations.
• Support preparation of technical documentation for CE Marking, UKCA, and FDA submissions.
• Prepare and submit FDA 510(k), DeNovo, Breakthrough and Pre-Submission documentation.
• Oversee regulatory compliance activities including HIPAA and future certifications such as MDSAP.
• Ensure compliance with FDA QSR - 21 CFR Part 820, ISO 13485 QMS, ISO 14971 risk management, and MDR requirements.
• Manage internal and external audits, maintaining readiness and documentation compliance.
• Coordinate cross-functional teams and facilitate effective communication.
• Utilize project management methodologies to ensure timely completion of regulatory initiatives.
• Maintain detailed documentation and oversee continuous improvement processes.

Benefits

• Competitive salary
• Remote-first setup with flexibility
• Career growth and development
• Inclusive and collaborative culture
• Travel opportunities