MedTech Risk Leader, R&D & Product Systems

Danaher; Poland; On-site; PLN 320,000 - 520,000; Full time

Job summary

Radiometer, a Danaher operating company, is seeking a Risk Manager – R&D Specialist for Product Systems. You will lead risk management across the full lifecycle of medical diagnostic devices, ensuring risks are identified, evaluated, controlled and monitored under ISO 14971.

You will partner with Systems Engineering, R&D, Quality, Regulatory Affairs, Manufacturing, Clinical and Post‑Market Surveillance to deliver safe, compliant products. Fluent English and 7+ years in Medtech required.

Qualifications

• Bachelor’s degree in Engineering, Science or similar with ISO 14971 expertise.
• 7+ years in Medtech development with risk management and systems engineering focus.
• Experience leading end‑to‑end risk management activities and risk documentation.
• Experience supporting regulatory submissions, audits and health authority interactions.
• Fluent in English.

Responsibilities

• Lead risk management activities across the full lifecycle of medical diagnostic devices.
• Identify, evaluate, control and monitor product risks in line with global standards.
• Partner with Systems Engineering, R&D, Quality, Regulatory, Manufacturing, Clinical and PMS teams to deliver safe, compliant products.

Skills

Risk Management

Systems Engineering

ISO 14971

Regulatory Submissions

Audits

English

Education

Bachelor’s degree in Engineering/Science or similar

Tools

Polarion

Job description

Radiometer, a Danaher operating company, is seeking a Risk Manager – R&D Specialist for Product Systems. You will lead risk management across the full lifecycle of medical diagnostic devices, ensuring risks are identified, evaluated, controlled and monitored under ISO 14971.

You will partner with Systems Engineering, R&D, Quality, Regulatory Affairs, Manufacturing, Clinical and Post‑Market Surveillance to deliver safe, compliant products. Fluent English and 7+ years in Medtech required.