Compliance Subject Matter Expert
My client is a global original equipment manufacturer located in Noord-Brabant. They strive to develop new technologies in the healthcare field and home appliances, using state-of-the-art technology and creating innovative consumer products for customers and stakeholders all around the world. They are market leading in medical IT applications, patient monitoring, home health care systems and other (health) related areas.
In this role, you have the opportunity to ensure process compliance to regulations, and that optimization and efficiency are built into the Management System and Quality Management System (MS/QMS) processes across all sectors and groups in partnership with the other business functions. Provide quality and regulatory support to End to End (E2E) Program teams to ensure the companies deployments are completed and maintaining compliance of the QMS during the transition period.
You are responsible for performing activities to ensure that the obligations of the Quality & Regulatory (Q&R) compliance domain are addressed. Responsibilities include keeping oversight of deployment projects and ensure E2E process content, validated software applications and QMS deployment deliverables will be available per the agreed schedule.
• Responsible for establishing an effective compliance framework in the Q&R domain and the adherence to it
• Responsible for embedding Q&R Compliance deliverables in project plans
• Coaches Business, Market and Function MS/QMS and Q&R teams on the deployment aspects of E2E Projects and creation of Local QMS Transition Plans
• Acts as the gate keeper for deployment of PEPF processes by measuring deployment readiness of PEPF processes
• Provide visibility on PEPF QMS Deployment statuses and Project Deployment Readiness
• Defines and recommends remediation and/or improvements actions
• Maintain the compliance catalogue for the Q&R domain, including the development and maintenance of the companies compliance standards, compliance requirements and (multidomain) compliance controls
• Bachelor’s degree, preferably in a scientific discipline
• Minimum of 7 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting multiple functional disciplines within a global medical device industry.
• Expert in understanding of applicable international and national laws, regulations and standards relevant to their domain.
• Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
• A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, complaint handling and post-market surveillance
Are you ready to take a new step in your career? If you are interested or know someone who is interested, please contact Leslie Fraser or upload your resume using the apply button.