Risk Management Expert
Fresenius Medical Care
full-time
Posted on:
Location Type: Hybrid
Location: Vršac • Serbia
Visit company websiteExplore more
About the role
- Lead the planning and execution of the risk management process in compliance with applicable standards and regulations.
- Develop, update, and maintain risk analyses and the Risk Management File across the product lifecycle.
- Define effective risk-reduction measures in collaboration with cross-functional partners and the Value Stream.
- Ensure all risk management activities align with the approved Risk Management Plan.
- Participate in product development and design reviews to verify proper risk identification and mitigation.
- Support and review Design/Process/Software FMEAs and anomaly management activities.
- Conduct and integrate risk assessments into the overall risk analysis.
- Provide risk management support during production transfer and ongoing manufacturing activities.
- Contribute to quality-system risk assessments (complaints, non-conformances, CAPAs) and Health Hazard Assessments.
- Support the creation of post-market safety documentation (e.g., PSUR, CER) and act as a subject matter expert for risk management within cross-functional teams.
Requirements
- Scientific degree and minimum 2 years of experience in Regulatory Affairs or Quality within the pharma/medical device industry.
- Proven experience in risk evaluations and strong knowledge of medical device regulations and standards (e.g., MDR, MDSAP, ISO 13485, ISO 14971).
- Experience in scientific writing and familiarity with statistical methods.
- Knowledge of medical devices, including dialysis and related therapies.
- Strong analytical, organizational, and decision-making skills, with an autonomous and structured working approach.
- Ability to work cross-functionally at all organizational levels, with excellent communication skills in an international environment.
- High engagement, proactive problem-solving attitude, and strong alignment with company values and objectives.
- Fluent English; advanced proficiency with MS Office, Outlook, SharePoint, Teams.
- Preferred: experience with TrackWise/QTRAK, PDM tools (e.g., Windchill), and FMEA tools.
Benefits
- Individual opportunities for self-determined career planning and professional development.
- A corporate culture in which there is enough room for innovative thinking.
- A large number of committed people with a wide range of skills, talents and experience.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
risk managementrisk analysisrisk evaluationscientific writingstatistical methodsFMEAmedical device regulationsISO 13485ISO 14971MDR
Soft Skills
analytical skillsorganizational skillsdecision-making skillscommunication skillsproblem-solving attitudecross-functional collaborationautonomous workingstructured working approachhigh engagementalignment with company values