Global Head of Quality and Regulatory Strategy

RetinAI Medical; Bern; On-site; CHF 180,000 - 300,000; Full time

Benefits offered by this job

Competitive salary

Professional growth

International environment

Travel opportunities

Job summary

Ikerian AG is seeking a Head of Quality & Regulatory Affairs (QRA) to lead the global QRA function from Bern, Switzerland. Drive regulatory strategy, ensure EU MDR compliance, and oversee SaMD product clearances while advancing the QMS and cross-functional collaboration.

You will manage an international QRA team, align with R&D, IT, and external partners, and steer audits and post-market surveillance to sustain world-class compliance and product excellence.

Qualifications

• Minimum 10 years leading cross-functional quality and regulatory teams.
• Minimum 5 years in medical devices QRA focused on SaMD.
• Proven PRRC experience with EU MDR and FDA submissions.
• Expert knowledge of ISO 13485, EU MDR, IEC 62304, ISO 14971; auditable.
• Strong governance for regulatory compliance across global markets.

Responsibilities

• Lead global QRA team across multiple time zones.
• Act as PRRC to ensure device conformity and regulatory compliance.
• Develop regulatory strategies for FDA submissions and CE-MDR.
• Maintain QMS (ISO 13485) and readiness for audits (MDSAP).
• Lead audits with Notified Bodies, authorities, and partners.
• Integrate design controls, risk management, and software lifecycles with R&D.
• Ensure GDPR and HIPAA data governance in quality processes.

Skills

Leadership

Regulatory strategy

PRRC

EU MDR

FDA submissions

QMS ISO 13485

IEC 62304

Risk management ISO 14971

Cross-functional collaboration

English communication

Education

University degree (Life Sciences/Biomedical Engineering/Law)

PhD or MBA asset

Tools

Lead Auditor certification

Job description

Ikerian AG is seeking a Head of Quality & Regulatory Affairs (QRA) to lead the global QRA function from Bern, Switzerland. Drive regulatory strategy, ensure EU MDR compliance, and oversee SaMD product clearances while advancing the QMS and cross-functional collaboration.

You will manage an international QRA team, align with R&D, IT, and external partners, and steer audits and post-market surveillance to sustain world-class compliance and product excellence.