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

Ikerian AG is a fast-growing medical device software company seeking a meticulous and driven QRA Specialist to strengthen their quality and regulatory operations. This role focuses on regulatory strategy, maintaining the Quality Management System (QMS), and ensuring compliance with international medical device regulations. The position requires a highly motivated professional with a background in EU/US Medical Device regulations.

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, facilitating effective communication and efficient project execution.
• Utilize project management methodologies to ensure timely completion of regulatory related initiatives.
• Maintain detailed documentation and oversee continuous improvement processes.
• Certification in Regulatory Affairs (RAC) is a plus.
• Prior experience managing MDSAP certification processes is a plus.

Benefits

• Opportunity to be part of a high-impact team
• Competitive salary and benefits
• Remote-first setup with flexibility and work-life balance
• Career growth and development in an international company
• Inclusive and collaborative culture
• Travel opportunities to HQ in Switzerland
• Provision of hardware/software for efficient remote work