Global Regulatory Affairs Specialist

Fresenius Medical Care; Reynosa; On-site; MXN 400,000 - 650,000; Full time

Job summary

Fresenius Medical Care, a global leader in kidney care, invites an Regulatory Affairs Expert to join the Reynosa plant in Mexico. You will manage regulatory documentation, support global registrations, ensure compliance, and lead regulatory aspects of product and process changes across the lifecycle.

You will collaborate with cross-functional teams to maintain technical documentation, develop IFU and labeling, coordinate submissions with authorities, and provide regulatory guidance on standards

Responsibilities

• Prepare, maintain, and manage Global Technical Documentation and Registration Files
• Develop and approve Instructions for Use (IFU), labeling, Service Manuals, and Installation Guides
• Provide regulatory guidance on applicable standards, regulations, and testing requirements
• Support design and development projects from a regulatory perspective
• Coordinate global submissions, registrations, renewals, and change notifications with Regulatory Authorities and Notified Bodies
• Conduct conformity assessments and support product risk classification activities
• Compile technical documentation, expert opinions, and risk evaluations supporting regulatory compliance
• Participate in change control processes and evaluate product and process changes from a regulatory perspective

Job description

Fresenius Medical Care, a global leader in kidney care, invites an Regulatory Affairs Expert to join the Reynosa plant in Mexico. You will manage regulatory documentation, support global registrations, ensure compliance, and lead regulatory aspects of product and process changes across the lifecycle.

You will collaborate with cross-functional teams to maintain technical documentation, develop IFU and labeling, coordinate submissions with authorities, and provide regulatory guidance on standards