Global Head of SaMD Quality & Regulatory Affairs

Ikerian AG; Bern; On-site; CHF 180,000 - 240,000; Full time

Benefits offered by this job

Global team

Competitive salary

Professional growth

Occasional travel

Bern HQ

Job summary

Ikerian AG, a Bern-based medical device software company, seeks a Head of Quality & Regulatory Affairs to lead global QRA, advance the QMS, and ensure EU MDR and FDA readiness across SaMD products.

You will oversee regulatory strategies, audits, and cross-functional collaboration with R&D, IT, and global affiliates, while driving privacy and cybersecurity compliance. CET business hours, on-site at Bern HQ.

Qualifications

• Degree in Life Sciences, Biomedical Engineering, Law or related field; PhD/MBA is a plus.
• At least 10 years leading cross-functional quality and regulatory teams.
• At least 5 years in medical device QRA focused on SaMD.
• Proven PRRC role with EU MDR and FDA submissions experience.
• Strong knowledge of ISO 13485, EU MDR, IEC 62304, ISO 14971, and 21 CFR Part 820.
• Lead Auditor certification is highly valued.
• Experience coordinating global regulatory strategies and audits.
• Excellent English communication; strong analytical skills.

Responsibilities

• Lead a global QRA team across time zones with accountability and development goals.
• Act as PRRC to ensure EU MDR conformity and manage technical files.
• Develop regulatory strategies for FDA submissions and CE-MDR compliance.
• Maintain QMS readiness for ISO 13485 and MDSAP across the org.
• Represent the company during audits with Notified Bodies and health authorities.
• Collaborate with R&D to integrate design controls and risk management early.
• Coordinate privacy/regulatory alignment with GDPR and HIPAA where applicable.
• Translate evolving regulations into proactive compliance roadmaps.

Skills

Leadership

Regulatory strategy

PRRC experience

FDA submissions

ISO 13485

IEC 62304

Risk management

Quality systems

English proficiency

Education

University degree in Life Sciences or related field

PhD or MBA (asset)

Job description

Ikerian AG, a Bern-based medical device software company, seeks a Head of Quality & Regulatory Affairs to lead global QRA, advance the QMS, and ensure EU MDR and FDA readiness across SaMD products.

You will oversee regulatory strategies, audits, and cross-functional collaboration with R&D, IT, and global affiliates, while driving privacy and cybersecurity compliance. CET business hours, on-site at Bern HQ.