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

Ikerian AG is seeking a meticulous and driven QRA Specialist to strengthen their quality and regulatory operations team. This role involves ensuring product compliance, preparing documentation, and managing regulatory activities, focusing on the EU MDR and FDA regulations. The company is a fast-growing medical device software company focused on AI and data management solutions for disease screening and monitoring.

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.
• 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, facilitating effective communication and efficient project execution.
• Utilize project management methodologies to ensure timely completion of regulatory related initiatives.

Benefits

• Opportunity to be part of a high-impact team
• Competitive salary and benefits
• Remote-first setup
• Career growth and development
• Inclusive and collaborative culture
• Travel opportunities
• Provision of hardware/software