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

Location: On-site in Stargard Szczecinski, Poland; occasional international travel for a few days per quarter.

Company

hirify.global operates Radiometer, a life sciences and diagnostics company developing solutions for fast, reliable patient diagnosis.

What you will do

• Lead risk management activities across the full lifecycle of medical diagnostic devices.
• Identify, evaluate, control, and monitor product risks in line with global regulatory and industry standards.
• Act as the subject-matter expert for ISO 14971.
• Develop, maintain, and approve risk management plans, analyses, benefit-risk assessments, and evaluation reports.
• Guide cross-functional hazard identification, risk analysis, and risk control with Systems Engineering, R&D, Quality, Regulatory Affairs, Manufacturing, Clinical, and Post-Market Surveillance teams.
• Support regulatory submissions, audits, health authority interactions, and updates to risk documentation based on field data.

Requirements

• Bachelor’s degree in Engineering, Science, or a related field.
• At least 7 years of hands-on experience in medtech development.
• Expertise in risk management and systems engineering, including proven ISO 14971 expertise.
• Experience executing end-to-end risk management activities across product development and sustaining phases.
• Experience supporting regulatory submissions, audits, health authority interactions, Post-Market Surveillance, Vigilance, and Complaint Handling.
• Fluent English required; the position is on-site in Stargard Szczecinski, Poland.

Nice to have

• Hands-on experience with lifecycle management or systems engineering tools such as Polarion.
• Working knowledge of ISO 13485 and IEC 62366, including usability engineering in risk management.

Culture & Benefits

• Comprehensive benefits including healthcare programs and paid time off.
• Culture focused on belonging, diverse perspectives, continuous improvement, and tangible impact on patient care.
• Opportunity to collaborate across international, cross-functional teams in life sciences and diagnostics.