Risk Manager - R&D Specialist, Product Systems (m/f/d)
Core
Leading and overseeing risk management activities across the full lifecycle of medical diagnostic devices to ensure compliance with global regulatory standards.
Role type
Senior IC risk management specialist (medical devices)
Builds
Safe, compliant, high-quality medical diagnostic devices
Domain
Life sciences, diagnostics, biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 14971 expertize, risk management, systems engineering, hazard identification, risk analysis, risk control, regulatory submission support, post-market surveillance evaluation
Preferred skills
lifecycle management tools, ISO 13485, IEC 62366, usability engineering integration
Technologies
Polarion
Responsibilities
Lead and oversee risk management activities across the full lifecycle of medical diagnostic devices; Ensure that product risks are systematically identified, evaluated, controlled, and monitored in compliance with global regulatory and industry standards; Serve as the subject-matter expert on ISO 14971, partnering closely with Systems Engineering, R&D, Quality, Regulatory Affairs, Manufacturing, Clinical, and Post-Market Surveillance teams; Support regulatory submissions, audits, and health authority interactions by providing clear, risk-based rationale and documentation; Partner with Post-Market Surveillance, Vigilance, and Complaint Handling teams to evaluate field data and update risk documentation as required
Seniority
Senior, hands-on IC