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

Ikerian AG, a rapidly growing medical device software company, is seeking a meticulous and driven Quality & Regulatory Affairs Specialist to bolster their regulatory operations team. This role focuses on ensuring product compliance with regulations such as FDA, EU MDR, and ISO 13485, and managing regulatory filings. The ideal candidate will thrive in a collaborative, fast-paced environment and contribute to a new, international company.

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.
• Maintain detailed documentation and oversee continuous improvement processes.
• 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 with flexibility
• Career growth and development
• Inclusive and collaborative culture
• Travel opportunities
• Provision of hardware/software for efficient remote work