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Sr Manager,Quality and Regulatory Operations – Neuenburg | JobRevolt

Über den Job

Masimo ist ein weltweit führendes Medizintechnik-Unternehmen, das eine breite Palette branchenführender Überwachungstechnologien entwickelt und produziert. Als Sr Manager, Quality & Regulatory Operations werden Sie die Regulatory- und Quality-Operationen anführen, um Compliance, Marktzugang und kommerziellen Erfolg zu unterstützen. Diese Rolle verbindet Regulatory-Expertise mit Quality Systems Leadership und erfordert starke medizinische Geräteerfahrung sowie die Fähigkeit, operationelle Exzellenz und Audit-Bereitschaft voranzutreiben.

Aufgaben

Lead RA/QA operations strategy and execution to support compliance and business growth
Drive regulatory and quality support for tenders, including requirement review, gap assessment, and compliant documentation
Oversee EUDAMED compliance (actor registration, device data, vigilance) and support maintenance of regulatory records
Support implementation and maintenance of UDI frameworks, ensuring alignment with EU and global UDI requirements
Manage and improve Quality Management System (QMS) processes, including CAPA, change control, deviations, and audit readiness

Profil

8–12+ years of experience in Regulatory Affairs and/or Quality Assurance within the medical device industry
Strong knowledge of EU MDR (2017/745), CE marking requirements, and European regulatory frameworks
Hands-on experience with EUDAMED and UDI implementation in alignment with global frameworks
Strong experience in Quality Management Systems (ISO 13485), including CAPA, audits, change control, and compliance processes
Fluent in English, any other language is a plus
Plus: Patient monitoring, hospital-based medical devices, digital health, or software-enabled medical technologies
Plus: 3–5+ years of people leadership or matrix leadership experience, including mentoring and influencing cross-functional teams
Plus: Working in EU-focused or global medtech organizations with exposure to multi-country quality and regulatory operations

Rahmenbedingungen

On-site role
Location: Route de -à-Bot 97, 2000 Neuchâtel
Reports to Sr Director, Quality & Regulatory Strategy
Part of Quality Compliance team

Sr Manager,Quality and Regulatory Operations

Über den Job

Über den Job

Aufgaben

Profil

Rahmenbedingungen

Skills

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