Regulatory Affairs Expert

Fresenius Medical Care AG; 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

Regulatory Affaris Expert

At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey.

Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 110,000 employees.

Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.

Our values guide how we work:

• We Care for our patients, each other, and our communities
• We Connect across teams and borders to deliver excellence together
• We Commit to doing things the right way—growing with purpose and leading kidney care with integrity and innovation

At our Reynosa plant in Mexico, we are committed to the highest standards in the production of disposable medical products for dialysis treatments. With a dedicated team of more than 3,000 employees across four manufacturing sites, the plant focuses on manufacturing essential components such as hemodialysis disposables, peritoneal dialysis (PD) disposables, hemodialysis (HD) machines, and PD cycler machines.

By utilizing advanced technologies to ensure the highest standards in dialysis product manufacturing, we’re not only driving innovation—we’re also creating meaningful change for patients worldwide. Join our passionate team and be part of this global impact.

The Regulatory Affairs Expert supports regulatory product availability on global markets in alignment with commercial strategy. This role is responsible for managing regulatory documentation, supporting global product registrations, ensuring regulatory compliance, and leading regulatory aspects of product and process changes throughout the product lifecycle.

Your 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