*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 vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 125,000 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

Systems, Quality \& Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s 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:

* Bachelor’s 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
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Good understanding of Quality \& Regulatory processes and compliance frameworks
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Good knowledge of ISO 9001, ISO 13485 standards and and ISO13485/MDR/GxP standards/regulations
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Ability to perform translations into English
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* 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)
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Based in Portugal, preferably based in Porto
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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