Risk Management and Design Control Specialist

Job summary

This role involves overseeing risk management for medical devices and ensuring compliance with design control procedures. The specialist will support lifecycle projects, focusing on maintaining high-quality products that meet safety standards for users with intimate healthcare needs.

Qualifications

• Scientific background
• Several years of experience in product risk assessment
• Experience in the medical device sector is preferred, but relevant experience from other sectors may be considered
• Fluent in English

Responsibilities

• Conduct hazard analyses and risk assessments
• Provide input on risk mitigation during the redesign process
• Develop documentation for each product
• Perform risk/benefit analyses
• Collaborate with colleagues across R&D, Product Support, Regulatory Affairs, Clinical and Medical Affairs, and commercial teams

Skills

• Strong analytical skills with a focus on safety and quality
• Ability to work collaboratively and network across the organization
• Structured approach to risk assessment

Education

• Relevant scientific degree or equivalent experience

Tools

• Familiarity with design control models and risk management frameworks