20 beste Stellen als it global lead in bern, be – aktuell auf Personalsuche

Head of QRA - Full Time - CH
RetinAI Medical —Bern, BE
- 100%
- Hybrides Arbeiten
- Doktorat
- Englisch
- Master
Direkt bewerben
1 Tag
Senior Manager Total Rewards EMEA
CSL Behring —Bern, BE
- 100%
- Microsoft Powerpoint
- Microsoft Excel
- Englisch
5 Tage
Director, Policy, Advocacy and Government Affairs Switzerland
CSL Behring —Bern, BE
- 100%
- Englisch
- Analysefähigkeit
5 Tage
Senior Scheme Manager (80-100%)
TWINT —Bern, BE
- Hybrides Arbeiten
- Microsoft Powerpoint
- Microsoft Excel
- Management-Erfahrung
- Homeoffice-Möglichkeit
- Eltern-/Erziehungsurlaub
2 Tage
Automatisierungstechniker
Mondelēz International —Bern, BE
- 100%
- Wartung
- Erfahrung in der IT
Marketing Coordinator (m/w/x)
CSL Behring —Bern, BE
- Teilzeit
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
2 Tage
Senior Computer System Validation Engineer (f/m/d)
Bavarian Nordic —Bern, BE
- 100%
- Informatik
- Englisch
- Master
1 Tag
Gruppenleiter:in Filling Line III (w/m/d)
CSL Behring —Bern, BE
- 100%
- Management-Erfahrung
- Personalführung
- PC-Kenntnisse
Manager Collectibles Strategic Programs
eBay Inc. —Bern, BE
- 100%
- Microsoft Powerpoint
- Microsoft Excel
- Master
EU Sr Program Manager
eBay Inc. —Bern, BE
- 100%
- Microsoft Powerpoint
- Microsoft Excel
- Master
Taste The Future - Maintenance Planning Intern (f/m/x)
Mondelēz International —Bern, BE
- 100%
- Microsoft Powerpoint
- Microsoft Excel
- Englisch
Senior Principal Scientist, Tech Ops (CMC Science) - Recombinant
CSL Behring —Bern, BE
- 100%
- Management-Erfahrung
- Doktorat
- Datenanalyse
Manager Product Care & Artwork Management
CSL Behring —Bern, BE
- 100%
- Management-Erfahrung
- Englisch
- Bachelor
Be-/Entlader (m/w/d) Frühschicht 07:30-09:30 , Mo-Fr (25%)
UPS —Seedorf, BE
- Teilzeit
- Erfahrung im Lager
da Vinci Clinical Territory Associate
Intuitive Surgical —Bern, BE
- Homeoffice
- Bis zu 50% Reiseanteil
- Englisch
- Bachelor
Strategic Buyer – Indirects (f/m/d) 80-100%
Twinings Ovaltine —Neuenegg, BE
- Hybrides Arbeiten
- Englisch
Direkt bewerben
Techniker vorbeugende Instandhaltung (m/w/d)
Mondelēz International —Bern, BE
- 100%
- Wartung
- Erfahrung in der IT
Manager Head of Metrology (m/w/x)
CSL Behring —Bern, BE
- 100%
- Englisch
- Bachelor
Enterprise Sales Lead - German Speaking
Valiantys —Bern, BE
- 100%
- Homeoffice
- Englisch
- Erfahrung mit Netzwerken
- Erfahrung in der IT
- Pendlerbeitrag
- Pensionskasse
Direkt bewerben
Pharma-Laborant/in – Qualitätskontrolle
CSL Behring —Bern, BE
- 100%
5 Tage

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Head of QRA - Full Time - CH

RetinAI Medical
Bern, BE

Direkt bewerben

Details zur Stelle

100% | Pensum: 90-100%
vor 1 Tag

Leistungen

Events zur Teambildung

Qualifikationen

Doktorat
Englisch
Master
Analysefähigkeit
Bachelor
Betriebswirtschaftslehre
Doktorat in Rechtswissenschaften
Kommunikationsfähigkeit
ISO 13485

Vollständige Stellenbeschreibung

About Us

Ikerian AG (formerly RetinAI Medical) is a fast-growing medical device software company headquartered in Bern, Switzerland. Our mission is to enable the right decisions sooner in healthcare, through transformative AI & data management solutions for disease screening and monitoring. Join our diverse team of entrepreneurs, developers, researchers, and commercial experts who are collectively shaping the future of healthcare.

Job Description

We are looking for a Head of Quality & Regulatory Affairs (QRA) to join our company in Bern, Switzerland. This role is pivotal in driving our internal operational maturity and ensuring global compliance across our expanding product portfolio. Following Ikerian’s acquisition by EssilorLuxottica, you will lead the evolution of the QRA department from a high-growth startup environment to a world-class subsidiary operation. You will oversee global product clearances for Software as a Medical Device (SaMD), optimize our Quality Management System (QMS), and serve as a strategic partner to internal R&D, Research, and global sister companies like Heidelberg Engineering.

Key Responsibilities

Lead and mentor a global QRA team located across various time zones, establishing a supportive, high-performance team culture driven by clear accountability, structured goal-setting, and skills development.
Act as the legal Person Responsible for Regulatory Compliance (PRRC) under EU MDR to ensure device conformity, keep technical documentation up to date, and oversee post-market surveillance and vigilance reporting obligations.
Develop and execute robust global regulatory strategies with an emphasis on securing and maintaining rapid market access via FDA submissions and CE-MDR compliance frameworks.
Govern and scale a world-class Quality Management System (QMS) ensuring continuous organizational readiness for ISO 13485 and the Medical Device Single Audit Program (MDSAP).
Serve as the primary corporate representative during all internal, Notified Body, partner, and health authority audits to ensure the continuous validation of corporate certifications.
Establish structured cross-functional alignment with R&D to seamlessly integrate design controls, risk management, and software lifecycles into early product development stages.
Partner with the IT Infrastructure and Security functions to support data privacy governance frameworks including GDPR and HIPAA compliance while aligning quality processes with emerging cybersecurity standards.
Translate market intelligence and evolving global regulations into proactive compliance roadmaps to ensure customer specifications and changing health authority standards are built into the corporate lifecycle.

Requirements

University degree in Life Sciences, Biomedical Engineering, Law, or a relevant scientific discipline; a PhD or MBA is a strong asset.
A minimum of 10 years of professional experience with a documented track record of successfully leading, managing, and mentoring cross-functional quality and regulatory teams.
A minimum of 8-10 years of dedicated industry experience in medical device Quality and Regulatory Affairs specifically focused on Software as a Medical Device (SaMD).
Proven track record as a legal Person Responsible for Regulatory Compliance (PRRC) with deep experience 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, and FDA 21 CFR Part 820. Formal Lead Auditor certification is highly valued.
Demonstrated ability to manage multi-faceted projects involving complex technical, clinical data, and regulatory evaluation components across international borders.
Excellent verbal and written English communication skills.
Strong analytical and problem-solving abilities with an exceptional eye for process detail, operational efficiency, and structural quality.
Demonstrated entrepreneurial and collaborative mindset with excellent team-building and conflict-resolution capabilities.
Ability to work independently as a leader.
Available to work during Central European Time (CET) business hours with a regular physical presence at our Bern headquarters.

Benefits

What We Offer

A chance to be part of an exceptional global team driving innovation in healthcare.
A competitive salary in a supportive work environment that fosters work-life balance.
Opportunities for professional growth and development in an international setting.
A culture of collaboration and inclusion, which is fundamental to our ethos.
Occasional travel to our HQ in Switzerland, immersing you in our core operations and company culture.

Direkt bewerben

Erweiterte Suche

it global lead Jobs in bern, be

Head of QRA - Full Time - CH

Senior Manager Total Rewards EMEA

Director, Policy, Advocacy and Government Affairs Switzerland

Senior Scheme Manager (80-100%)

Automatisierungstechniker

Marketing Coordinator (m/w/x)

Senior Computer System Validation Engineer (f/m/d)

Gruppenleiter:in Filling Line III (w/m/d)

Manager Collectibles Strategic Programs

EU Sr Program Manager

Taste The Future - Maintenance Planning Intern (f/m/x)

Senior Principal Scientist, Tech Ops (CMC Science) - Recombinant

Manager Product Care & Artwork Management

Be-/Entlader (m/w/d) Frühschicht 07:30-09:30 , Mo-Fr (25%)

da Vinci Clinical Territory Associate

Strategic Buyer – Indirects (f/m/d) 80-100%

Techniker vorbeugende Instandhaltung (m/w/d)

Manager Head of Metrology (m/w/x)

Enterprise Sales Lead - German Speaking

Pharma-Laborant/in – Qualitätskontrolle

Ich möchte aktuelle Job-E-Mails für Stellen als it global lead in bern, be erhalten

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