Risk Management and Design Control Specialist

Job summary

This role involves overseeing risk management for medical devices and ensuring adherence to design control procedures. The specialist will support lifecycle projects, focusing on maintaining product safety and performance for continence and bowel care products.

Qualifications

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

Responsibilities

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

Skills

• Strong analytical skills with a curiosity to understand product technicalities and user needs
• Ability to work collaboratively and network across the organization

Education

• Relevant scientific degree or equivalent experience

Tools

• Familiarity with risk management and design control tools and methodologies