RetinAI Medical
Healthcare
HeadofQRA
Neural analysis suggests this role is
optimal for Lead candidates.
“Head of QRA at RetinAI Medical. Skills: Quality Management System, Regulatory Affairs, EU MDR, FDA submissions. Lead and mentor a global QRA team. Establish a supportive, high-performance team culture”
Industry & Context.
Problem-solving; Analytical skills
Physical presence at Bern headquarters, Work during Central European Time (CET) business hours
What They're Looking For.
Must Have
University degree in Life Sciences, Biomedical Engineering, Law, or relevant scientific field, 10+ years professional experience leading quality and regulatory teams, 8-10 years industry experience in medical device Quality and Regulatory Affairs, Experience as a legal Person Responsible for Regulatory Compliance (PRRC), Experience managing complex technical files for EU MDR and FDA submissions, Expert technical knowledge of ISO 13485, Expert technical knowledge of EU MDR, Expert technical knowledge of IEC 62304 software lifecycles, Expert technical knowledge of ISO 14971 risk management, Expert technical knowledge of FDA 21 CFR Part 820, Demonstrated ability to manage multi-faceted projects internationally, Excellent verbal and written English communication skills, Analytical and problem-solving abilities, Exceptional eye for process detail, Exceptional eye for operational efficiency, Exceptional eye for structural quality, Demonstrated entrepreneurial mindset, Demonstrated collaborative mindset, Excellent team-building capabilities, Excellent conflict-resolution capabilities, Ability to work independently as a leader
Nice to Have
PhD or MBA is an asset, Formal Lead Auditor certification is highly valued
What You'll Do.
Lead and mentor a global QRA team
Establish a supportive
high-performance team culture
Act as the legal Person Responsible for Regulatory
Ensure device conformity
Keep technical documentation up to date
Oversee post-market surveillance
Oversee vigilance reporting obligations
Develop global regulatory strategies
Execute global regulatory strategies
Secure and maintain rapid market access
Govern a world-class Quality Management System (QMS)
Scale a world-class Quality Management System (QMS)
Ensure organizational readiness for ISO 13485
Ensure organizational readiness for MDSAP
Serve as the primary corporate representative during audits
Ensure continuous validation of corporate certifications
Establish cross-functional alignment with R&D
Integrate design controls into product development
Integrate risk management into product development
Integrate software lifecycles into product development
Support data privacy governance frameworks
Align quality processes with cybersecurity standards
Translate market intelligence into compliance roadmaps
Translate evolving global regulations into compliance roadmaps
How You'll Work.
Team & Collaboration
Global QRA team; Cross-functional alignment with R&D; Partner with IT Infrastructure; Partner with Security functions; Work with sister companies
Communication Scope
Verbal communication; Written communication
Process & Methodology
Project management
Full Job Description
### About Us [Ikerian AG (formerly RetinAI Medical)](http://www.retinai.com) 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 **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 Responsibilities * 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. * 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. * 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. * 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). * Serve as the primary corpo
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