About the Company

Our client is a leading innovator in the medical‑device sector, dedicated to delivering safe, high‑performance solutions that improve patient outcomes worldwide. With a strong focus on regulatory excellence and cutting‑edge technology, the organization maintains a robust portfolio of devices across diagnostics, therapeutic, and monitoring categories. The culture emphasizes continuous improvement, scientific rigor, and a commitment to compliance, making it a trusted partner for healthcare providers.

Role Overview

The company is seeking an experienced Risk Manager to lead the assessment, control, and minimisation of risks associated with its medical device portfolio. This pivotal role ensures product safety and regulatory compliance throughout the product lifecycle, collaborating closely with R&D, Quality Management, and Regulatory Affairs teams.

Key Responsibilities

• Risk Management Leadership – Develop, implement, and continuously improve risk management processes in line with ISO 14971.
• Risk Analyses – Conduct comprehensive risk assessments for new and existing medical devices, identifying hazards, estimating risks, and defining mitigation strategies.
• Documentation – Create, maintain, and update risk management files and technical documentation to meet regulatory standards.
• Cross‑Functional Collaboration – Partner with R&D, Quality Management, and Regulatory Affairs to integrate risk controls into product design and development.
• Audit & Inspection Support – Provide expert support during internal audits, external regulatory inspections, and certification activities.
• Training & Mentoring – Deliver training sessions on risk‑related topics to employees at all levels, fostering a culture of safety and compliance.

Required Qualifications

• Education – Degree in Engineering, Natural Sciences, or a comparable field.
• Experience – Minimum 5 years of professional experience in risk management within the medical device industry.
• Regulatory Expertise – Deep knowledge of ISO 14971 and relevant regulations (MDR, FDA).
• Technical Documentation – Proven ability to produce and manage risk management files and related technical documentation.
• Skills – Strong analytical thinking, structured working style, and excellent communication abilities.
• Languages – Very good written and spoken German and English.

Desired Attributes

• Proactive mindset with a focus on continuous improvement.
• Ability to influence and drive risk‑aware decisions across multidisciplinary teams.
• Strong organizational skills and attention to detail.

What Is Offered

• Opportunity to shape risk management strategy for cutting‑edge medical devices.
• Collaborative environment with cross‑functional expertise.
• Competitive compensation package and professional development support.