About the role
<h3>About Us</h3><p><a href="http://www.retinai.com" rel="nofollow noreferrer noopener">Ikerian AG (formerly RetinAI Medical)</a> 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.</p><h3>Job Description</h3><p>We are looking for a <strong>Head of Quality & Regulatory Affairs (QRA)</strong> to join our company in Bern, Switzerland. This role is pivotal in driving our internal operational maturity and ensuring global compliance across our expanding product portfolio. Following Ikerian’s acquisition by EssilorLuxottica, you will lead the evolution of the QRA department from a high-growth startup environment to a world-class subsidiary operation. You will oversee global product clearances for Software as a Medical Device (SaMD), optimize our Quality Management System (QMS), and serve as a strategic partner to internal R&D, Research, and global sister companies like Heidelberg Engineering. <br /><br />Key Responsibilities</p><ul><li>Lead and mentor a global QRA team located across various time zones, establishing a supportive, high-performance team culture driven by clear accountability, structured goal-setting, and skills development.</li><li>Act as the legal Person Responsible for Regulatory Compliance (PRRC) under EU MDR to ensure device conformity, keep technical documentation up to date, and oversee post-market surveillance and vigilance reporting obligations.</li><li>Develop and execute robust global regulatory strategies with an emphasis on securing and maintaining rapid market access via FDA submissions and CE-MDR compliance frameworks.</li><li>Govern and scale a world-class Quality Management System (QMS) ensuring continuous organizational readiness for ISO 13485 and the Medical Device Single Audit Program (MDSAP).</li><li>Serve as the primary corporate representative during all internal, Notified Body, partner, and health authority audits to ensure the continuous validation of corporate certifications.</li><li>Establish structured cross-functional alignment with R&D to seamlessly integrate design controls, risk management, and software lifecycles into early product development stages.</li><li>Partner with the IT Infrastructure and Security functions to support data privacy governance frameworks including GDPR and HIPAA compliance while aligning quality processes with emerging cybersecurity standards.</li><li>Translate market intelligence and evolving global regulations into proactive compliance roadmaps to ensure customer specifications and changing health authority standards are built into the corporate lifecycle.</li></ul><p></p>