About UsIkerian 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.About UsIkerian 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 DescriptionWe are looking for a Head of Quality & Regulatory Affairs (QRA) 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.Key ResponsibilitiesLead 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 developmentAct 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 obligationsDevelop and execute robust global regulatory strategies with an emphasis on securing and maintaining rapid market access via FDA submissions and CE-MDR compliance frameworksGovern and scale a world-class Quality Management System (QMS) ensuring continuous organizational readiness for ISO 13485 and the Medical Device Single Audit Program (MDSAP)Serve as the primary corporate representative during all internal, Notified Body, partner, and health authority audits to ensure the continuous validation of corporate certificationsEstablish structured cross-functional alignment with R&D to seamlessly integrate design controls, risk management, and software lifecycles into early product development stagesPartner 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 standardsTranslate market intelligence and evolving global regulations into proactive compliance roadmaps to ensure customer specifications and changing health authority standards are built into the corporate lifecycleRequirementsUniversity degree in Life Sciences, Biomedical Engineering, Law, or a relevant scientific discipline; a PhD or MBA is a strong assetA minimum of 10 years of professional experience with a documented track record of successfully leading, managing, and mentoring cross-functional quality and regulatory teamsA minimum of 5 years of dedicated industry experience in medical device Quality and Regulatory Affairs specifically focused on Software as a Medical Device (SaMD)Proven track record as a legal Person Responsible for Regulatory Compliance (PRRC) with deep experience managing complex technical files for EU MDR and FDA submissionsExpert technical knowledge of ISO 13485, EU MDR, IEC 62304 software lifecycles, ISO 14971 risk management, and FDA 21 CFR Part 820. Formal Lead Auditor certification is highly valuedDemonstrated ability to manage multi-faceted projects involving complex technical, clinical data, and regulatory evaluation components across international bordersExcellent verbal and written English communication skillsStrong analytical and problem-solving abilities with an exceptional eye for process detail, operational efficiency, and structural qualityDemonstrated entrepreneurial and collaborative mindset with excellent team-building and conflict-resolution capabilitiesAbility to work independently as a leaderAvailable to work during Central European Time (CET) business hours with a regular physical presence at our Bern headquartersBenefitsWhat We OfferA chance to be part of an exceptional global team driving innovation in healthcareA competitive salary in a supportive work environment that fosters work-life balanceOpportunities for professional growth and development in an international settingA culture of collaboration and inclusion, which is fundamental to our ethosOccasional travel to our HQ in Switzerland, immersing you in our core operations and company culture #J-18808-Ljbffr
Head of QRA - Full Time - CH in Bern Arbeitgeber: Ikerian AG
Die Ikerian AG ist ein hervorragender Arbeitgeber, der in Bern, Schweiz, eine dynamische Arbeitsumgebung bietet, in der Innovation im Gesundheitswesen gefördert wird. Mit wettbewerbsfähigen Gehältern, umfangreichen Möglichkeiten zur beruflichen Weiterentwicklung und einer kollaborativen Unternehmenskultur ist dies der ideale Ort für Cloud Engineers, die ihre Fähigkeiten in AWS und IaC weiterentwickeln möchten.
