Expert Quality & Regulatory EMEA

Expert Quality & Regulatory EMEA

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 125000 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

Systems Quality & Regulatory (SQR) a global function within Care Enablement ensuring Fresenius Medical Cares products meet the highest standards of quality safety and regulatory compliance throughout the entire product lifecycle. The team supports market access innovation and patient safety by driving excellence across manufacturing and supply chain overseeing post-market surveillance and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide!

Your Responsibilities as Expert Quality & Regulatory EMEA:

Q&R Administrative Compliance & Documentation Governance
Design implement and maintain an efficient document management system
Manage daily documentation activities and ensure consistency with internal policies and regulatory requirements
Prepare presentations executive summaries structured reports and data overviews to support leadership decision-making
Generate consolidated periodic reports and maintain data transparency for management review.
Manage in documenting and updating internal processes and changes.
Coordinate translations of departmental documents ensuring consistency and accuracy across regions where required
Contribute to regional and cross-functional operational improvement initiatives
Support the implementation monitoring and optimization of dedicated Q&R systems IT and digital tools.
Organize meetings track action items and ensure timely follow-up on decisions and deliverables.
Coordinate business travel and support the organization of internal and external events in alignment with corporate policies

Data & Project Management
Maintain and support databases used for statistical data collection and reporting.
Support in the implementation and follow-up of Q&R projects and related IT tools.
Contribute to project execution by ensuring alignment with established processes procedures and Q&R compliance
standards.
Prepare project status reports outlining progress challenges risks and proposed solutions using appropriate data
management tools.
Support the development and application of standardized methods and tools to effectively organize and manage Q&R project
activities.
Collaborate with functional and operational leaders across the organization to facilitate smooth transitions and successful
project delivery

Your Profile:

Bachelors degree in Business Administration Quality Management Regulatory Affairs Life Sciences Health Sciences or a related field
Certification in documentation Management

At least 2 years of professional experience in documentation management administration quality management system
regulatory affairs compliance administration or comparable
Experience in processing documentation and controls
Experience working within a regulated environment (e.g. healthcare MedTech pharma or similar)
Hands-on experience with document management systems reporting tools and digital collaboration platforms
Knowledge of documentation control principles and data integrity practices

Good knowledge of documentation control principles and data integrity practices

Good understanding of Quality & Regulatory processes and compliance frameworks

Good knowledge of ISO 9001 ISO 13485 standards and and ISO13485/MDR/GxP standards/regulations

Ability to perform translations into English

Proficient in MS Office applications (Excel Word PowerPoint ) and collaboration tools (e.g. Sharepoint Teams) at a good level and
ability to adapt to new technologies
Knowledge or competence to work with PowerBI and AI tools

Fluent in English (written and spoken)

Based in Portugal preferably based in Porto

Our Offer For You:

There is a lot you can discover at Fresenius Medical Care regardless of which field you are an expert and how much experience you have - all dedicated to your professional journey.

• Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world

• Individual opportunities for self-determined career planning and professional development

• A corporate culture in which there is enough room for innovative thinking - to find the best solution together not the quickest one

• A large number of committed people with a wide range of skills talents and experience

• The benefits of a successful global corporation with the collegial culture of a medium-sized company
• Health insurance
• Life insurance
• Meal allowance
• Hybrid work