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

About Us

Ikerian AG (formerly RetinAI Medical) is a fast-growing medical device software company headquartered in Bern, Switzerland. Our mission is to enable the right decisions sooner in healthcare, through transformative AI & data management solutions for disease screening and monitoring. Join our diverse team of entrepreneurs, developers, researchers, and commercial experts who are collectively shaping the future of healthcare.

Job Description

We are looking for a meticulous and driven QRA Specialist to strengthen our quality and regulatory operations team. This role is ideal for a highly motivated professional with a background in SaMD/MDSW regulations (EU & US), who thrives in a collaborative, fast-paced environment. The QRA Specialist will contribute to regulatory strategies, maintain our QMS, and ensure compliance with international medical device regulations and standards.

Key Responsibilities:

• 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, managing all aspects of CDRH and other related regulatory filings.
• 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 to enhance operational efficiency and compliance.

Requirements:

• University degree in Regulatory Affairs or related field.
• 3+ years of experience in medical device quality and regulatory affairs.
• Deep knowledge of ISO 13485, EU MDR, IEC 62304, ISO 14971, and FDA 21 CFR Part 820.
• Proven experience with EU MDR and FDA submissions.
• Experience with audits (Notified Bodies & FDA).
• Strong project management and cross-functional collaboration skills.
• Excellent communication in English (spoken & written).
• Ability to travel occasionally.
• If based in Switzerland, Tuesday presence in the office in Bern is obligatory.
• Certification in Regulatory Affairs (RAC) is a plus.
• Prior experience managing MDSAP certification processes is a plus.