Head of Quality & Regulatory Affairs (SaMD)

Ikerian AG; Bern; Sur place; CHF 180 000 - 280 000; Plein temps

Avantages offerts par ce poste

Salary competitive

International growth and development

Occasional travel to HQ

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory strategy

Quality Management

PRRC experience

EU MDR expertise

FDA submissions

ISO 13485

Cross-functional leadership

Clinical data handling

Formation

Master's degree in Life Sciences or Biomedical Engineering

PhD or MBA asset

Outils

Lead Auditor certification

Description du poste

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.