Ikerian AG
Head of Operations(m/w/x)
Vollzeitnur vor OrtSenior
Bern
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RERetinAI Medical
Head of Quality & Regulatory Affairs - QRA(m/w/x)
VollzeitVor OrtSenior
AI/ML
Nejo KI-Zusammenfassung
Leading global QRA team for AI medical device software, acting as legal PRRC under EU MDR. Minimum 10 years QRA leadership and 8 years SaMD experience required. Occasional travel, professional growth opportunities.
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Anforderungen
- University degree in Life Sciences, Biomedical Engineering, Law, or relevant scientific discipline
- PhD or MBA is a strong asset
- Minimum 10 years professional experience leading, managing, mentoring cross-functional quality and regulatory teams
- Minimum 8-10 years industry experience in medical device Quality and Regulatory Affairs for SaMD
- Proven track record as legal PRRC 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, FDA 21 CFR Part 820
- Formal Lead Auditor certification is highly valued
- Ability to manage multi-faceted projects with complex technical, clinical data, and regulatory evaluation components internationally
- Excellent verbal and written English communication skills
- Strong analytical and problem-solving abilities
- Exceptional eye for process detail, operational efficiency, and structural quality
- Demonstrated entrepreneurial and collaborative mindset
- Excellent team-building and conflict-resolution capabilities
- Ability to work independently as a leader
- Availability to work during Central European Time (CET) business hours
- Regular physical presence at Bern headquarters
Aufgaben
- Lead and mentor a global QRA team
- Establish a supportive, high-performance team culture
- Drive clear accountability and structured goal-setting
- Develop team members' skills
- Act as the legal Person Responsible for Regulatory Compliance (PRRC) under EU MDR
- Ensure device conformity and maintain technical documentation
- Oversee post-market surveillance and vigilance reporting
- Develop and execute global regulatory strategies
- Secure and maintain rapid market access via FDA submissions
- Ensure CE-MDR compliance
- Govern and scale a world-class Quality Management System (QMS)
- Ensure continuous organizational readiness for ISO 13485 and MDSAP
- Represent the company during internal, Notified Body, and health authority audits
- Ensure continuous validation of corporate certifications
- Establish cross-functional alignment with R&D
- Integrate design controls, risk management, and software lifecycles into early product development
- Partner with IT Infrastructure and Security functions
- Support data privacy governance frameworks (GDPR, HIPAA)
- Align quality processes with emerging cybersecurity standards
- Translate market intelligence into proactive compliance roadmaps
- Ensure customer specifications and changing health authority standards are built into the corporate lifecycle
Berufserfahrung
8 - 10 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
ISO 13485EU MDRIEC 62304ISO 14971FDA 21 CFR Part 820
Benefits
Startup-Atmosphäre
- Supportive work environment
Flexibles Arbeiten
- Work-life balance
Weiterbildungsangebote
- Professional growth and development
Lockere Unternehmenskultur
- Culture of collaboration and inclusion
Sonstige Vorteile
- Occasional travel
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens RetinAI Medical erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei RetinAI MedicalÜber das Unternehmen
RE
HealthcareBern
Ikerian AG is a fast-growing medical device software company enabling better healthcare decisions with AI solutions.
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