Sr Manager, Quality and Regulatory Operations (Medical Devices)

Формат работы

onsite

Тип работы

fulltime

Грейд

senior

Английский

Страна

Switzerland

Вакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:

TL;DR

Sr Manager, Quality and Regulatory Operations (Medical Devices): Leading regulatory affairs and quality operations for medical device compliance, market access, and commercial support with an accent on EU MDR, EUDAMED, UDI, and quality systems. Focus on assessing tender requirements, maintaining regulatory records, improving QMS processes, and ensuring CAPA, audit, and post-market readiness.

Location: On-site in Neuchâtel, Switzerland

Company

Masimo is a hirify.global operating company that develops medical monitoring technologies, sensors, patient monitors, and automation and connectivity solutions.

What you will do

Lead regulatory affairs and quality assurance operations strategy and execution to support compliance and business growth.
Support medical device tenders through requirement reviews, gap assessments, and compliant documentation.
Oversee EUDAMED compliance, including actor registration, device data, vigilance, and regulatory records.
Support implementation and maintenance of UDI frameworks aligned with EU and global requirements.
Manage and improve QMS processes, including CAPA, change control, deviations, and audit readiness.
Partner with Commercial, Contracts, and cross-functional teams to interpret requirements and implement practical solutions.

Requirements

8–12+ years of Regulatory Affairs and/or Quality Assurance experience in the medical device industry.
Strong knowledge of EU MDR (2017/745), CE marking, and European regulatory frameworks.
Hands-on experience with EUDAMED and UDI implementation aligned with global frameworks.
Strong experience with Quality Management Systems under ISO 13485, including CAPA, audits, change control, and compliance processes.
Fluent English required.

Nice to have

Experience with patient monitoring, hospital-based medical devices, digital health, or software-enabled medical technologies.
3–5+ years of people leadership or matrix leadership experience.
Experience in EU-focused or global medtech organizations with multi-country quality and regulatory operations.
Additional language skills.

Culture & Benefits

Culture focused on belonging, continuous improvement, innovation, and tangible impact in life sciences.
Healthcare programs and paid time off are included among the benefits.
Work within a global medical technology organization supporting clinicians and patient care.

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