Roche
Healthcare
RegulatoryAffairsManager(m/w/d)
Neural analysis suggests this role is
optimal for Mid candidates.
“Regulatory Affairs Manager (m/w/d) at Roche. Skills: Regulatory Affairs, IVD/MD instrument & software approvals, Global regulatory requirements. Leading and supporting regulatory strategies for global IVD/MD instrument & software approvals, especially in the area of cross-laboratory automation. Ensuring compliance with international regulatory requirements and standards”
Industry & Context.
What They're Looking For.
Must Have
Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field, 5 to 10 years of professional experience in Regulatory Affairs (Regulatory, R&D, Quality, and/or Clinical Research), ideally with initial experience in the healthcare sector, Solid knowledge of global regulatory requirements, guidelines, and procedures, especially for IVD instruments & software, Strong organizational skills, Strong communication skills, Ability to effectively manage multiple projects simultaneously, Self-motivated work style that allows you to operate in a self-directed environment, Experience in the development of IVD instruments and/or software, ideally in the area of Laboratory Automation
Nice to Have
Experience in the healthcare sector, Experience in Laboratory Automation
What You'll Do.
Leading and supporting regulatory strategies for global IVD/MD instrument & software approvals
especially in the area of cross-laboratory automation
Ensuring compliance with international regulatory requirements and standards
Providing expert advice to support product development and lifecycle management
Continuously monitoring regulatory trends and updates and implementing best practices
How You'll Work.
Team & Collaboration
Collaboration with cross-functional teams (such as R&D, Quality, and Clinical Research) to drive regulatory initiatives
Communication Scope
Strong communication skills
Process & Methodology
Ability to effectively manage multiple projects simultaneously
Full Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. ### ### The Position Bei Roche glauben wir daran, dass es dringend notwendig ist, medizinische Lösungen sofort bereitzustellen – während wir gleichzeitig an Innovationen für die Zukunft forschen. Wir setzen uns leidenschaftlich dafür ein, das Leben von Patient:innen zu verbessern, und wir sind mutig in unseren Entscheidungen und Taten. Wir sind überzeugt: Gutes Geschäft bedeutet eine bessere Welt. **Verantwortlichkeiten | Das erwartet Dich** * Die Leitung und Unterstützung regulatorischer Strategien für globale IVD/MD-Instrumenten- & Software-Zulassungen, insbesondere im Bereich der laborübergreifenden Automatisierung. * Die Sicherstellung der Einhaltung internationaler regulatorischer Anforderungen und Standards. * Die Zusammenarbeit mit funktionsübergreifenden Teams (wie F&E, Qualität und Klinische Forschung), um regulatorische Initiativen voranzutreiben. * Die Bereitstellung fachlicher Beratung zur Unterstützung der Produktentwicklung sowie des Lifecycle-Managements. * Die kontinuierliche Beobachtung regulatorischer Trends und Updates sowie die Implementierung von Best Practices. **Qualifikationen | Das bringst Du mit** * Ein erfolgreich abgeschlossenes Bachelor-Studium in Life Sciences, Regulatory Affairs oder einem verwandten Bereich. * 5 bis 10 Jahre Berufserfahrung im Bereich Regulatory Affairs (Regulatorik, F&E, Qualität und/oder Klinische Forschung), idealerweise mit erster Erfahrung im Gesundheitswesen. * Fundierte Kenntnisse der globalen regulatorischen Anforderungen, Richtlinien und Verfahren, insbeson
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