Cluster Expert for Medical Device Regulatory Affairs and Vigilance 

Cluster Expert for Medical Device Regulatory Affairs and Vigilance

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

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!

The Cluster Expert oversees all medical device regulatory activities across an assigned EMEA cluster, ensuring timely, compliant market authorisations and ongoing product availability. The role provides regulatory expertise across the full product lifecycle covering submissions, assessments, registrations, renewals, vigilance, and post‑market surveillance.

They ensure continuous compliance, manage regulatory risks, and support business continuity and patient safety. The position also leads a team of Country/Cluster Experts to deliver consistent, high‑quality regulatory and post‑market activities.

Your Responsibilities:

Regulatory Activities-Medical Device:

• Assess registration files to ensure the content complies with regulatory requirements.
• Prepare and submit documentation for product approvals, registrations, and renewals.

Stakeholder Management & Communication:

• Interface with government agencies and regulatory bodies to ensure timely approvals and resolve any issues.
• Manage inquiries by promptly responding to regulatory bodies’ requests with the necessary data or explanations during the approval process.
• Provide advice and recommendations to local management on regulatory policy and strategies to accelerate regulatory approvals while ensuring compliance.

Regulatory Compliance & Intelligence:

• Monitor the regulatory environment and ensure full compliance with relevant legislation and internal SOPs.
• Update and implement local regulatory procedures.
• Ensure timely approvals, identify regulatory trends, and stay up to date with legislation in the countries under your responsibility.

Post Market surveillance- Medical Device:

• Manage regulatory aspects of a product from development through to post-market surveillance by fulfilling the role of Local Safety Officer (LSO):
• Implement and maintain a Medical Device Vigilance system according to corporate requirements and in compliance with local regulations.
• Perform post-market surveillance and vigilance activities, including related reporting and documentation.
• Prepare and submit competent authority notifications for medical device incidents and Field Safety Corrective Actions (FSCAs).

Training and Development:

• Provide regulatory training to relevant staff members and departments as needed.
• Keep up to date with the latest developments in regulatory affairs through continuous education and professional development

Your Profile:

• At least 5 - 8 years of experience in a similar position
• Bachelor’s degree in in a relevant field (e.g. Pharmacy, Pharmaceutical Sciences, Life Sciences, Biochemistry, Biology, or Chemistry).
• Minimum 5 years’ experience in regulatory affairs in the MedTech /Pharma industry industries
• Minimum of 5 years’ experience in regulatory submissions, filings, and compliance
• Minimum of 5 years of experience in the MedTech industry
• Extensive experience in processing documentation and controls
• Expertise in cross-functional coordination at regional level
• Good knowledge in applicable legal and regulatory laws of the countries in scope
• Good knowledge of 9001, 13485, GxP regulations, MDR, GDPR
• High language proficiency in English (written and spoken)
• Slovak and Czech languages are a must
• Other languages are an asset as Hungarian
• Willingness to travel as required

Our Offer For You:

There is a lot you can discover at Fresenius Medical Care, regardless in 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