Head of Quality & Regulatory Affairs (QRA)

About the role

Ikerian AG, a medical device software company based in Bern, Switzerland, is looking for a Head of Quality & Regulatory Affairs (QRA) to lead its QRA department after its acquisition by EssilorLuxottica. The role drives internal operational maturity and global compliance across the growing product portfolio, oversees global product clearances for Software as a Medical Device (SaMD), optimizes the Quality Management System (QMS) and acts as a strategic partner to R&D, research and sister companies.

Key responsibilities

• Lead and mentor a global QRA team across time zones, building a high-performance culture with clear accountability, goal-setting and skills development.
• Act as the legal Person Responsible for Regulatory Compliance (PRRC) under EU MDR, keeping technical documentation current and overseeing post-market surveillance and vigilance reporting.
• Develop global regulatory strategies, including FDA submissions and CE-MDR compliance, to secure and maintain rapid market access.
• Govern and scale the QMS so the organization remains ready for ISO 13485 and the Medical Device Single Audit Program (MDSAP).
• Represent the company in audits with internal teams, Notified Bodies, partners and health authorities.
• Align with R&D on design controls, risk management and software lifecycles, and with IT and security on GDPR and HIPAA data privacy and cybersecurity standards.
• Turn market intelligence and regulatory changes into proactive compliance roadmaps.

Required profile

• University degree in Life Sciences, Biomedical Engineering, Law or a related scientific discipline; a PhD or MBA is a strong asset.
• At least 10 years of professional experience leading, managing and mentoring cross-functional quality and regulatory teams.
• At least 5 years in medical device Quality and Regulatory Affairs, focused on SaMD.
• Proven PRRC experience managing complex technical files for EU MDR and FDA submissions.
• Ability to manage complex, international projects and to work independently as a leader.
• Available during Central European Time (CET) business hours with a regular physical presence in Bern.

Required skills

• Expert knowledge of ISO 13485, EU MDR, IEC 62304, ISO 14971 and FDA 21 CFR Part 820.
• Formal Lead Auditor certification is highly valued.
• Excellent written and spoken English.

What we offer

• A competitive salary in a supportive environment that fosters work-life balance.
• Professional growth opportunities in an international setting.
• A culture of collaboration and inclusion.
• Occasional travel to the Swiss headquarters.