I am looking for a PMS/Risk Specialist to join a Medical Equipment Manufacturing organisation based in Scotland.
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.
JOB PURPOSE:
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.
MAIN ACTIVITIES AND 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 Surveillance (PMS) activities for products in adherence with the required schedules to ensure regulatory compliance
• Create and/or update PMS documentation in line with IVDR requirements and in accordance with the agreed PMS schedule (PMS Plan, SSP, PMS Report, PSUR)
• Ensure Product Risk Management & PMS Process efficiency according KPIs.
• Act as a Risk Management Team Representative during Third Party Audit
• Promote risk culture including Risk Based Approach and Continuous Improvement
• Participate in regulatory inspections or certification audits as part of the Quality Systems Team
• Contribute to the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance documents and industry standards relating to your related areas of responsibility
• Providing support, guidance and training as needed to fellow team members in the areas of Risk Management and PMS
• Perform any other duties as reasonably requested from the Company from time to time.
• Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements
If you're interested in this role, please apply with your updated CV.
For more information please send me a message - jamie.keith@cpl.com