Head of QRA - Full Time - CH

Ikerian AG, a rapidly expanding medical‑device software firm based in Bern, Switzerland, develops AI‑driven data‑management tools for disease screening and monitoring. The company is seeking a Head of Quality & Regulatory Affairs (QRA) to guide the transformation of its QRA function from a startup mindset into a world‑class subsidiary following the recent acquisition by EssilorLuxottica. In this position you will direct a globally dispersed QRA team, fostering a high‑performance culture through clear accountability and skill development. You will act as the legal Person Responsible for Regulatory Compliance under EU MDR, maintain technical documentation, and manage post‑market surveillance and vigilance reporting. Your duties also include shaping global regulatory strategies for rapid FDA and CE‑MDR market entry, overseeing a robust Quality Management System aligned with ISO 13485 and MDSAP, and representing the company during audits. Close collaboration with R&D, IT, and security functions will be required to embed design controls, risk management, and data‑privacy standards such as GDPR and HIPAA into product development. Candidates must hold a university degree in life sciences, biomedical engineering, law, or a related scientific field, with a PhD or MBA regarded as advantageous. At least ten years of experience leading cross‑functional quality and regulatory teams, and five years focused on SaMD within the medical‑device sector, are essential. Proven PRRC status, deep familiarity with EU MDR, FDA submissions, ISO 13485, IEC 62304, ISO 14971, and a formal Lead Auditor certification are strongly valued. Fluency in English, strong analytical skills, and the ability to work independently during CET business hours are required. The role offers a competitive salary, a supportive environment that emphasizes work‑life balance, and opportunities for international professional growth. Regular presence at the Bern headquarters is expected, with occasional travel to immerse in the core company culture and collaborate within a diverse, inclusive global team.