Regulatory Affairs Expert

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 visionCreating a future worth living. For patients. Worldwide. Every work with purpose and compassion supported by a global team of over 110000 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 waygrowing 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 3000 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 were not only driving innovationwere 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
Act as regulatory lead for change-related initiatives and global implementation activities
Draft and review Declarations of Conformity and other compliance documentation
Maintain product information applicable standards and regulatory records
Support tender activities and responses to regulatory authority requests

Your Profile

Bachelors degree in Biomedical Engineering Technical Engineering Life Sciences or related discipline
35 years of experience in Regulatory Affairs or Quality Assurance within the Medical Device or Pharmaceutical industry
Minimum 2 years of experience in development manufacturing or quality control of medical devices and/or medicinal products
Knowledge of medical device regulations (MDR 2017/745 MDD 93/42/EEC) and global registration requirements
Knowledge of quality and risk management standards (ISO 13485 ISO 14971 FDA 21 CFR GMP guidelines)
Understanding of sterilization processes clean room requirements and validation methods
Experience managing technical documentation regulatory submissions and product registrations
Experience with Microsoft Office; knowledge of QTRAK PTC Windchill and FMEA tools preferred
Strong communication and collaboration skills across global cross-functional teams
Proactive solution-oriented mindset with a focus on continuous improvement
Bilingual (English/Spanish)
U.S. Visa required

Our Offer for You

There is a lot you can discover at Fresenius Medical Care regardless of the field of expertise or level of experienceeverything is dedicated to supporting your professional journey.

Whether in front of or behind the scenes you help make better medicine available to more people worldwide
Individual opportunities for selfdetermined career planning and professional development
A corporate culture that encourages innovative thinkingfinding the best solution together not just the fastest one
A team of committed professionals with diverse skills talents and experiences
The strength of a successful global corporation combined with the collegial culture of a midsized company.