RetinAI Medical
Head of Quality & Regulatory Affairs - QRA(m/w/x)
Vollzeitnur vor OrtSenior
Bern
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Synchronizing R&D and commercial engines for AI/data management solutions in MedTech software. Proven track record in operational integration and scaling companies from small to mid-sized required. Supportive environment, work-life balance.
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Anforderungen
- University degree in Business, Law, Engineering, or relevant scientific field; MBA or PhD preferred
- Proven track record in operational integration within MedTech Software industry, Health Information Technology
- Minimum 10 years leadership experience, scaling company from small to mid-sized
- Expertise in building and professionalizing "Operating Systems" to synchronize cross-functional teams
- Strong foundation in Information Architecture and Knowledge Management, structuring digital workspaces
- Direct experience navigating complex regulatory pathways (FDA or MDR) or regulated environments, managing QMS
- Ability to manage multi-faceted projects involving technical, legal, and human resource components
- Exceptional stakeholder management skills and collaborative mindset leading diverse, international teams
- Strong analytical and problem-solving abilities, eye for operational detail and financial efficiency
- Ability to work independently as executive leader and core company leadership member
- Excellent verbal and written English communication skills
- Current residency in Switzerland or willingness to relocate, ability to work from Bern HQ
Aufgaben
- Install a high-performance operating system
- Synchronize Research, Development, and Commercial engines
- Lead cross-functional teams including Project Management, HR, and Quality & Regulatory Affairs
- Professionalize vendor management and internal knowledge infrastructure
- Evolve from a high-growth startup to a world-class subsidiary
- Ensure robust, compliant, and transparent operational framework
- Direct core operational departments and mentor PMO, QRA, and HR heads
- Implement structured operating system for organizational alignment
- Optimize organizational design and workflows for efficient scaling
- Modernize and govern internal knowledge infrastructure and digital workspace
- Design and lead company-wide objective-setting framework
- Translate strategic goals into measurable departmental targets
- Professionalize vendor management lifecycle
- Oversee selection, compliance, and performance of external service providers
- Lead legal compliance and manage corporate risk
- Support post-merger integration with global standards
- Maintain organizational agility and innovation speed
- Direct Project Management Office for disciplined execution
- Oversee HR and Talent Acquisition strategy
- Foster high-performance culture and attract world-class talent
- Drive high-level Regulatory and Quality strategy
- Ensure global product clearances (e.g., FDA 510(k)/De Novo and EU MDR)
Berufserfahrung
10 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Benefits
Attraktive Vergütung
- Competitive compensation package
Startup-Atmosphäre
- Supportive environment
Flexibles Arbeiten
- Work-life balance
Sinnstiftende Arbeit
- Meaningful innovation for patients
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Ikerian AG 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 Ikerian AGÜber das Unternehmen
IK
HealthcareBern
Ikerian AG is a medical device software company providing AI and data management solutions for healthcare, aiming to enable earlier decisions in disease screening and monitoring.
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