Regulatory Affairs Expert

CH01 CHE Fresenius Medical Care (Schweiz) AG; Reynosa; On-site; MXN 520,000 - 860,000; Full time

Job summary

Fresenius Medical Care Reynosa plant seeks a Regulatory Affairs Expert to ensure compliance for dialysis disposables, HD/PD devices, and related products.

You will prepare global technical documents, support regulatory submissions, and guide product approvals while collaborating with cross-functional teams worldwide.

The ideal candidate holds a Biomedical Engineering degree, 3–5 years in regulatory affairs, bilingual English/Spanish, and a US visa.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Technical Engineering, Life Sciences, or related field.
• 3–5 years in Regulatory Affairs or Quality Assurance in Medical Device or Pharmaceutical industry.
• 2+ years 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.
• Experience with regulatory submissions, documentation, and product registrations.

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.
• Draft and review Declarations of Conformity and other compliance documentation.

Skills

Regulatory Affairs

Quality Assurance

Documentation management

Cross-functional collaboration

Bilingual English/Spanish

Education

Biomedical Engineering degree

Tools

QTRAK

Windchill

FMEA

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.

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

• Bachelor’s degree in Biomedical Engineering, Technical Engineering, Life Sciences, or related discipline
• 3-5 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

• Whether in front of or behind the scenes, you help make better medicine available to more people worldwide
• Individual opportunities for self-determined career planning and professional development
• A corporate culture that encourages innovative thinking - finding 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 mid-sized company.

Fresenius Medical Care is the world's leading provider of products and services for individuals with kidney disease of which approximately 4.5 million patients worldwide regularly undergo dialysis treatment. United by a shared purpose of creating a future worth living for chronically and critically ill people, we care for around 292,000 dialysis patients around the globe. In addition, we operate around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables. We aim to continuously improve our patients’ quality of life by offering them high-quality products as well as innovative technologies and treatment concepts.