Drug Quality & Regulatory Expert (Pre & Post‑Market) - Spain

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 Drug Quality & Regulatory Expert (Pre & Post‑Market) - Spain: This role is responsible for ensuring full regulatory compliance across the entire lifecycle of medicinal products, from development and market authorization to post-market surveillance and distribution, within Spain.

Key responsibilities include:

Regulatory Leadership:
Drive and manage all regulatory activities to secure timely approvals, product launches, and lifecycle maintenance in full compliance with local and international regulations.
Stakeholder Management:
Act as the primary point of contact with health authorities and internal teams, supporting audits, inspections, and ensuring effective cross-functional collaboration (Sales, Marketing, Supply Chain).
Pharmacovigilance (PVRP):
Oversee local PV activities, including adverse event reporting, PSUR/RMP submissions, regulatory intelligence, audit readiness, and act as the key liaison with the EU QPPV.
Regulatory Affairs:
Lead submissions, renewals, and maintenance of marketing authorizations, ensuring compliance with national requirements, managing product information, and supporting global regulatory teams.
Supply Chain Quality & GDP:
Ensure compliance with Good Distribution Practices (GDP), oversee distributors and logistics partners, and manage audits, recalls, and temperature-controlled distribution processes.
Regulatory Compliance & Intelligence:
Monitor regulatory changes, provide strategic guidance, and ensure implementation of local requirements while proactively sharing insights with stakeholders.
Governance & Continuous Improvement:
Drive process optimization, digitalization initiatives, and deliver GxP training while maintaining KPIs and compliance standards.

Your Profile:

Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Biology, Biochemistry, Bioengineering, Health Sciences, or related field
Advanced training in Regulatory Affairs and Pharmacovigilance
5–8 years of relevant experience, including:
- Minimum 5 years in Regulatory Affairs (Pharma/MedTech)
- Strong experience in regulatory submissions, filings, and compliance
Fluency in English and Spanish (additional languages are a plus)
Strong expertise in Regulatory Affairs, Pharmacovigilance, and GDP
Proven experience managing regulatory submissions and compliance
Excellent stakeholder management and communication skills
Ability to manage multiple projects and deadlines in a complex regulatory environment
Deep knowledge of Spanish regulations and international standards (GxP, ISO)

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
Hybrid work

In accordance with Organic Law 3/2007, of 22 March, FME has set itself the objective of promoting the effective application of the principle of equality between men and women, avoiding any type of labour discrimination based on sex, thus guaranteeing the same opportunities for entry. Likewise, we promote diversity, rejecting any type of discrimination for reasons of race, sex, functional diversity, religion, sexual orientation, sexual identity, or any other personal or social condition, and we are committed to building an inclusive and enriching environment

Drug Quality & Regulatory Expert – Pre & Post‑Market (Spain)

Fresenius Group

Job Description

Drug Quality & Regulatory Expert (Pre & Post‑Market) - Spain

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