Risk Manager
Core
Systematically identify, assess, and minimize risks across the product lifecycle to ensure product safety in medical technology and industrial automation.
Role type
Risk Manager (Medical Device/Regulatory)
Builds
Robust risk management systems and compliant risk files for medical devices and automation solutions.
Domain
MedTech / Industrial Automation
Required skills
ISO 14971, ISO 13485, FMEA, product lifecycle risk management, post-market surveillance, vigilance data analysis, CAPA management, validation support, risk culture promotion
Preferred skills
None stated
Technologies
ISO 14971, ISO 13485, FMEA
Responsibilities
Establish and develop the risk management system per ISO 14971; moderate risk analyses (FMEA) with cross-functional teams; create and maintain compliant risk files; analyze complaints and market data to identify trends; accompany audits and regulatory inspections; train colleagues on risk management methodology; support validation of design, process, and test methods.
Seniority
Mid-Senior, hands-on IC
