A Risk Management Engineer is required to apply regulatory and engineering knowledge to deliver risk management files (RMF) for a device designed and manufactured by SHL Medical. The candidate will work with customers and internal stakeholders to outline the company's risk management scope and deliver the RMF in compliance with ISO standards.
Main Responsibilities:
* Participate in project intake activities to assess feasibility from a risk management perspective.
* Communicate with customers and their representatives to request and review medical harm lists that meet company requirements.
* Initiate risk management plans and align overall risk management deliverables with stakeholders and customers.
* Review FMEA reports for content accuracy and risk control measures applied.
* Attend project meetings to ensure relevant information is captured and utilized effectively.
* Participate in product lifecycle management activities to provide/collect information and update risk management documents periodically.
* Participate in internal and external audits and inspections to ensure regulatory compliance.
* Maintain periodic review of post-market data with supervisor and RA personnel.
* Cascade updated risk management file information to risk assessment and project teams.
* Contribute to device risk management process improvement activities and gap remediations.
* Evaluate potential issues and changes impacting device risk management files and participate in recovery plans.
* Maintain communication with customers to ensure engagement and information exchange.
* Stay updated on regulatory changes and escalate for discussion with the Risk Manager.