Recruiter's Glossary

Examples: FDA 21 CFR Part 820 • Medical Grade Materials • IQ/OQ/PQ

Risk Management

Term from Medical Device Manufacturing industry explained for recruiters

Risk Management in medical device manufacturing is a systematic process of identifying, analyzing, and preventing potential problems that could affect patient safety or product quality. It's like having a thorough safety check system that helps companies identify what could go wrong with their medical devices before problems occur. Companies use Risk Management to make sure their products are safe, meet regulatory requirements (like FDA rules), and work as intended. This is a crucial part of medical device development, similar to quality control but more focused on preventing issues before they happen rather than just checking final products.

Examples in Resumes

Led Risk Management assessment for Class II medical devices according to ISO 14971

Developed and maintained Risk Management files for cardiovascular product line

Implemented Risk Management processes that achieved 100% regulatory compliance

Conducted Risk Management reviews and Risk Analysis for new product development

Typical job title: "Risk Management Specialists"

Also try searching for:

Risk Management Engineer Quality Engineer Medical Device Safety Specialist Regulatory Affairs Specialist Product Safety Engineer Quality Assurance Engineer Risk Assessment Specialist

Where to Find Risk Management Specialists

Professional Organizations

Online Communities

• LinkedIn Medical Device Groups
• Reddit r/medicaldevices

Job Boards

• MedTech Careers
• LinkedIn Medical Device Jobs

Example Interview Questions

Senior Level Questions

Q: How would you handle a situation where a risk assessment reveals a serious safety concern in a product that's already in production?

Expected Answer: A senior professional should discuss a systematic approach: immediately documenting the finding, assessing the impact on patient safety, forming a cross-functional team, developing both short-term and long-term solutions, and ensuring proper communication with regulatory bodies if needed.

Q: How do you ensure risk management processes stay current with changing regulations?

Expected Answer: Should explain methods for monitoring regulatory changes, updating documentation systems, training teams, and implementing new requirements while maintaining continuous compliance.

Mid Level Questions

Q: What documentation is essential in a risk management file?

Expected Answer: Should mention risk analysis reports, risk evaluation criteria, risk control measures, and traceability matrix, explaining each in simple terms and their importance.

Q: How do you determine acceptable risk levels for a medical device?

Expected Answer: Should discuss balancing benefits against risks, using standards like ISO 14971, considering similar products in the market, and involving various stakeholders in the decision process.

Junior Level Questions

Q: What is a risk assessment and why is it important?

Expected Answer: Should explain that risk assessment is a process of identifying potential problems that could harm patients or affect product quality, and why it's crucial in medical device manufacturing.

Q: What are the basic steps of the risk management process?

Expected Answer: Should describe the main steps: identifying potential risks, analyzing their severity and likelihood, implementing controls, and monitoring their effectiveness.