Risk Manager - R&D Specialist, Product Systems (m/f/d)

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

Risk Manager – R&D Specialist, Product Systems (m/f/d)

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Radiometer, one of Danaher's 15+ operating companies, our work saves lives and we are united by a shared commitment to innovate for tangible impact. You will thrive in a culture of belonging where your unique viewpoint matters. Harnessing Danaher's system of continuous improvement helps you turn ideas into impact, innovating at the speed of life. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We celebrate diversity and continuous improvement, providing a place to grow and make a real impact.

In this role, you will have the opportunity to:

• 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 to deliver safe, compliant, high‑quality products.

The essential requirements of the job include:

• A minimum bachelor’s degree in Engineering, Science or similar with proven ISO 14971 expertise.
• 7+ years of hands‑on experience in Medtech development, with strong expertise in Risk Management and Systems Engineering.
• Proven ability to lead and execute end‑to‑end risk management activities, including developing, maintaining, and approving risk management plans, analyses, benefit‑risk assessments, and evaluation reports, while guiding cross‑functional hazard identification, risk analysis, and risk control across product development and sustaining phases.
• Experience supporting regulatory submissions, audits, and health authority interactions by providing clear, risk‑based rationale and documentation.
• Ability to partner with Post‑Market Surveillance, Vigilance, and Complaint Handling teams to evaluate field data and update risk documentation as required.
• Fluent in English.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel – a few days travels abroad per quarter.

It would be a plus if you also possess previous experience in:

• Hands‑on use of lifecycle management or systems engineering tools (e.g., Polarion or equivalent).
• Working knowledge of ISO 13485 and IEC 62366, with a strong emphasis on integrating usability engineering into risk management practices.

Benefits

Radiometer, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to your life. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.