Switzerland | Hybrid
ISO 14971 | Risk-Based Development | Medical Devices | MDR | Product Development
For an internationally active MedTech company in Switzerland, we are looking for an experienced professional to lead and further develop product risk management within the product development organization.
This role combines strategic responsibility with hands‑on expertise in risk-based development of medical devices and offers the opportunity to shape and strengthen risk management processes across development projects.
Responsibilities
Lead and further develop the product risk management function
Ensure implementation of ISO 14971-compliant risk management processes
Act as the central expert for product risk management across development projects
Support cross-functional development teams in risk-based product development
Facilitate risk analyses such as FMEA, hazard analysis and risk evaluations
Ensure robust risk documentation and audit readiness
Drive continuous improvement of risk management processes and tools
Contribute to post-market risk management, including evaluation of field data and benefit-risk assessments
Requirements
Degree in engineering, biomedical engineering or life sciences
Strong experience in risk management for medical devices
Deep knowledge of ISO 14971, EU MDR and FDA expectations
Structured, pragmatic and solution-oriented working style
Leadership experience or strong potential to lead a team
Excellent communication skills and ability to moderate technical discussions
Compensation
Base salary range: CHF 140'000 – CHF 160'000 depending on experience
Additional performance-related bonus Hybrid working model (up to 2 days home office)
Example Background Candidates may currently work as:
Risk Manager – Medical Devices
Design Assurance Engineer
Senior Quality Engineer – Risk Management
Systems Safety / Product Safety Engineer
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Senior Risk Manager - Fr.140'000 - Fr.160'000 A Year in Bern Arbeitgeber: Karakas Recruiting
Als Arbeitgeber in der MedTech-Branche bieten wir Ihnen die Möglichkeit, in einem dynamischen und innovativen Umfeld zu arbeiten, das auf Qualität und Sicherheit ausgerichtet ist. Unsere Unternehmenskultur fördert Teamarbeit und kontinuierliche Weiterbildung, sodass Sie Ihre Fähigkeiten weiterentwickeln und Karrierechancen nutzen können. Zudem profitieren Sie von attraktiven Vergütungen und einem modernen Arbeitsumfeld, das Ihre Work-Life-Balance unterstützt.
