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

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

Miejsce pracy: Stargard

Your 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 to deliver safe, compliant, high-quality products.

Our requirements

• A minimum bachelor’s degree in Engineering, Science or similar with proven ISO 14971 expertize.
• 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.
• Ability to travel – a few days travels abroad per quarter.

Optional

• 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

• sharing the costs of sports activities
• private medical care
• sharing the costs of foreign language classes
• sharing the costs of professional training & courses
• life insurance
• fruits
• integration events
• coffee / tea
• drinks
• parking space for employees
• pre-paid cards
• holiday funds
• christmas gifts
• employee referral program

The Risk Manager - R&D Specialist, Product Systems (m/f/d) is responsible for leading and overseeing risk management activities across the full lifecycle of medical diagnostic devices at Radiometer, a Danaher operating company.

This position reports to the R&D Director and is part of the Samplers Development team located at Radiometer in Stargard and will be an on-site role.

Radiometer Solutions Sp. z o.o.

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’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We’re a team that celebrates diverse ideas and continuous improvement. Here, you’ll find a place to grow and make a real impact, with your unique perspective driving us forward in improving patient care. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

Prosimy o dopisanie klauzuli: "Wyrażam zgodę na przetwarzanie moich danych osobowych dla potrzeb niezbędnych do realizacji procesu rekrutacji zgodnie z Rozporządzeniem Parlamentu Europejskiego i Rady (UE) 2016/679 z dnia 27 kwietnia 2016 r. w sprawie ochrony osób fizycznych w związku z przetwarzaniem danych osobowych i w sprawie swobodnego przepływu takich danych oraz uchylenia dyrektywy 95/46/WE (RODO)."