MedTech Regulatory & Quality Operations Manager

Radiometer; Neuenburg; On-site; CHF 140,000 - 190,000; Full time

Job summary

Masimo Neuchâtel, Switzerland, seeks a Manager of Quality & Regulatory Operations to lead regulatory and quality activities on-site. You will partner with Commercial, Contracts, and cross-functional teams to ensure compliance and market access for EU and global medical devices.

The role requires deep knowledge of EU MDR, ISO 13485, EUDAMED, and UDI, with strong CAPA and audit experience. Fluency in English is essential; this on-site position offers a dynamic environment driving regulatory

Qualifications

• 4–6+ years of experience in regulatory affairs and/or quality assurance in medical devices.
• Strong knowledge of EU MDR (2017/745) and CE marking.
• Hands-on experience with EUDAMED and UDI implementation.
• Experience with ISO 13485, CAPA, audits, and change control.

Responsibilities

• Lead RA/QA operations to support compliance and market access.
• Collaborate with cross-functional teams to prepare tenders and regulatory submissions.
• Ensure EU and global regulatory alignment and maintain regulatory records.
• Support implementation and maintenance of QMS processes, including CAPA and audits.

Skills

Regulatory affairs

Quality assurance

EU MDR

EUDAMED

UDI

ISO 13485

CAPA

Audit readiness

English (Fluent)

Job description

Masimo Neuchâtel, Switzerland, seeks a Manager of Quality & Regulatory Operations to lead regulatory and quality activities on-site. You will partner with Commercial, Contracts, and cross-functional teams to ensure compliance and market access for EU and global medical devices.

The role requires deep knowledge of EU MDR, ISO 13485, EUDAMED, and UDI, with strong CAPA and audit experience. Fluency in English is essential; this on-site position offers a dynamic environment driving regulatory