Head of QRA - Full Time - CH

Ikerian AG; Bern; On-site; CHF 180,000 - 280,000; Full time

Benefits offered by this job

Salary competitive

International growth and development

Occasional travel to HQ

Job summary

Ikerian AG in Bern, Switzerland, is seeking a Head of Quality & Regulatory Affairs (QRA) to drive regulatory excellence across our SaMD portfolio. You will lead global QRA efforts, ensure EU MDR/PRRC conformity, and optimize the Quality Management System while partnering with R&D and global teams.

You will oversee FDA submissions, CE-MDR compliance, post-market surveillance, and audits, shaping a world-class subsidiary operation following EssilorLuxottica's acquisition.

Qualifications

• University degree in Life Sciences, Biomedical Engineering, Law, or relevant field.
• PhD or MBA is a strong asset.
• At least 10 years leading quality/regulatory teams.
• 5+ years SaMD regulatory experience.
• Proven PRRC experience.
• Knowledge of ISO 13485, EU MDR, IEC 62304, ISO 14971, and FDA 21 CFR Part 820.
• Fluent English; CET hours; Bern presence.

Responsibilities

• Lead and mentor a global QRA team across time zones with accountability and clear goals.
• Act as PRRC under EU MDR to ensure device conformity and documentation.
• Develop and execute global regulatory strategies for FDA submissions and CE/MDR.
• Govern and scale a QMS for ISO 13485 and MDSAP readiness.
• Represent the company during Notified Body, audits, and health authority reviews.
• Align cross-functionally with R&D to integrate design controls and software lifecycles.
• Support data privacy governance with GDPR and HIPAA compliance.

Skills

Regulatory strategy

Quality Management

PRRC experience

EU MDR expertise

FDA submissions

ISO 13485

Cross-functional leadership

Clinical data handling

Education

Master's degree in Life Sciences or Biomedical Engineering

PhD or MBA asset

Tools

Lead Auditor certification

Job description

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.

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 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 corporate representative during all internal, Notified Body, partner, and health authority audits to ensure the continuous validation of corporate certifications
• Establish structured cross-functional alignment with R&D to seamlessly integrate design controls, risk management, and software lifecycles into early product development stages
• 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
• 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

Requirements

• University degree in Life Sciences, Biomedical Engineering, Law, or a relevant scientific discipline; a PhD or MBA is a strong asset
• A minimum of 10 years of professional experience with a documented track record of successfully leading, managing, and mentoring cross-functional quality and regulatory teams
• A 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 submissions
• Expert 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 valued
• Demonstrated ability to manage multi-faceted projects involving complex technical, clinical data, and regulatory evaluation components across international borders
• Excellent verbal and written English communication skills
• Strong analytical and problem-solving abilities with an exceptional eye for process detail, operational efficiency, and structural quality
• Demonstrated entrepreneurial and collaborative mindset with excellent team-building and conflict-resolution capabilities
• Ability to work independently as a leader
• Available to work during Central European Time (CET) business hours with a regular physical presence at our Bern headquarters

Benefits

What We Offer

• A chance to be part of an exceptional global team driving innovation in healthcare
• A competitive salary in a supportive work environment that fosters work-life balance
• Opportunities for professional growth and development in an international setting
• A culture of collaboration and inclusion, which is fundamental to our ethos
• Occasional travel to our HQ in Switzerland, immersing you in our core operations and company culture