20 beste Stellen als compliance in berne be – aktuell auf Personalsuche

Head of QRA - Full Time - CH
RetinAI Medical —Bern, BE
- 100%
- Hybrides Arbeiten
- Doktorat
- Englisch
- Master
Direkt bewerben
3 Tage
Legal Counsel
Bridge Et Al. —Bern, BE
- Management-Erfahrung
- Englisch
- Kommunikationsfähigkeit
Site ERP Deployment Lead, Production and Supply Chain
Bavarian Nordic —Bern, BE
- 100%
- Microsoft Excel
- Englisch
- Erfahrung in der IT
CAPEX & engineering lead
Swiss Biotech Association —Aarberg, BE
Managing Director China
Blaser Swisslube AG —Hasle, BE
- 100%
- Vertrieb
- Produktion
- Kommunikationsfähigkeit
Data Science Specialist
Nestlé —Konolfingen, BE
- Überstunden
- Informatik
- Englisch
- Master
Expert Projektleiter (m/w/d) CAFM & BIM - Digitalisierung & öffentliche Beschaffung (60%) (Ref.Nr.: 46965)
Wavestone Germany AG —Bern, BE
- Teilzeit
- Homeoffice
- Microsoft Powerpoint
- Microsoft Excel
- Englisch
Direkt bewerben
22 Std.
CISO / Head of IT Security - Fulltime Hybrid
RetinAI Medical —Bern, BE
- 100%
- Hybrides Arbeiten
- Management-Erfahrung
- AWS
- Bachelor
Direkt bewerben
Koordinator/-in Marketing Schweizer Pavillon an der Expo Belgrad
Bundesverwaltung - Eidgenössisches Departement für auswärtige Angelegenheiten EDA —Bern, BE
- Englisch
- Microsoft Office
- Master
Inspektor/in
Bundesverwaltung - Staatssekretariat für Wirtschaft SECO —Bern, BE
Global Reliability Engineering Lead
CSL Behring —Bern, BE
- 100%
- Management-Erfahrung
- Wartung
- Master
Senior Principal Scientist, Tech Ops (CMC Science) - Recombinant
CSL Behring —Bern, BE
- 100%
- Management-Erfahrung
- Doktorat
- Datenanalyse
Intermediate Structural Engineer (Switzerland)
Aspect Structural Engineers —Bern, BE
- CHF 85’000 - CHF 90’000 pro Jahr
- Master
- Analysefähigkeit
- Bachelor
- Bezahlte Ferien
Direkt bewerben
Audit (Assistant) Manager - Financial Services - Competence Center
PwC —Bern, BE
- 100%
- Englisch
- Rechnungswesen
Entreprise-Architect
Bundesverwaltung - Staatssekretariat für Wirtschaft SECO —Bern, BE
- Management-Erfahrung
- Englisch
- Master
Warehouse Operator
Blaser Swisslube AG —Hasle, BE
- 100%
- Microsoft Outlook
- Wartung
- Maturität
PKI Security Officer Operator
Bundesverwaltung - Eidgenössisches Justiz- und Polizeidepartement EJPD —Bern, BE
- Englisch
- Erfahrung in der IT
Thai Massage Therapist
OASIA Kehrsatz —Kehrsatz, BE
- CHF 25 - CHF 40 pro Stunde
- Teilzeit
- Englisch
- Kostenloser Parkplatz
Direkt bewerben
10 Tage
Customer Service Coordinator
SGS —Brügg, BE
- 100%
- Microsoft Outlook
- Englisch
- Microsoft Office
Direkt bewerben
Business Analyst IAM (Senior Expert)
Bundesverwaltung - Staatssekretariat für Wirtschaft SECO —Bern, BE
- Englisch
- Master
- Bachelor

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Head of QRA - Full Time - CH

RetinAI Medical
Bern, BE

Direkt bewerben

Details zur Stelle

100% | Pensum: 90-100%
vor 3 Tagen

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

compliance Jobs in berne be

Head of QRA - Full Time - CH

Legal Counsel

Site ERP Deployment Lead, Production and Supply Chain

CAPEX & engineering lead

Managing Director China

Data Science Specialist

Expert Projektleiter (m/w/d) CAFM & BIM - Digitalisierung & öffentliche Beschaffung (60%) (Ref.Nr.: 46965)

CISO / Head of IT Security - Fulltime Hybrid

Koordinator/-in Marketing Schweizer Pavillon an der Expo Belgrad

Inspektor/in

Global Reliability Engineering Lead

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

Intermediate Structural Engineer (Switzerland)

Audit (Assistant) Manager - Financial Services - Competence Center

Entreprise-Architect

Warehouse Operator

PKI Security Officer Operator

Thai Massage Therapist

Customer Service Coordinator

Business Analyst IAM (Senior Expert)

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