Job Description
Job Role
Are you looking to join a global Medical Equipment Manufacturing organisation who are looking to empower diagnostic insights, transform patient care, and innovate for life?
The PMS/Risk Specialist role is part of the Quality Systems team who is responsible for the management of the various quality systems, including the product Post Market Surveillance (PMS) and Product Risk Management Files throughout the entire life cycle of the Products.
The focus of this position is to ensure, through completion of the relevant Product Risk and Product Post Market Surveillance (PMS) activities, that products are maintained in compliance with all relevant Regulations. As part of this job, the PMS/Risk Specialist will manage risk throughout the entire Design Control Process for new projects and through Core QMS processes (such as Non-Conforming Product management, Change Management, Complaint Management) for Products on the market.
Key Responsibilities
• Ensure Product Risk Management Processes are compliant with relevant Risk Management Regulations.
• Lead and/or support all Product Risk Management activities according to current procedures
• Create new and update existing Product Risk Management Documentation to ensure compliance with current procedures
• Carry out Post Market Surveill...