Drug Quality & Regulatory Expert (Pre & Post‐Market) - SpainAt 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.
Core Values
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) is 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 SQR team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post‐marketing surveillance, and promoting continuous improvement and system harmonisation. 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!
ResponsibilitiesAs the Drug Quality & Regulatory Expert (Pre & Post‐Market) for Spain, you will ensure that the entire lifecycle of the medication—from registration through post‐marketing surveillance and distribution—complies with national and international regulations, ensuring quality, patient safety, and business continuity.
Ensure efficient and compliant regulatory processes in Spain, supporting market authorisation, product launch, distribution and sustained product availability.
Manage regulatory activities across the full product lifecycle, including development, registration, post‐market surveillance and supply chain quality, with a strong focus on PVRP and GDP compliance.
Prepare, submit and maintain regulatory dossiers and documentation in line with local and regional requirements.
Promote consistent regulatory strategies and practices and collaborate with key stakeholders and health authorities.
Monitor regulatory changes, ensure inspection readiness, manage compliance risks and provide expert regulatory and quality guidance to internal teams.
Profile & Qualifications
Minimum BA university degree in Pharmacy, Pharmaceutical Sciences, Biochemistry, Biology, Bioengineering, Health Sciences or similar.
Advanced training in regulatory affairs of medicinal products and pharmacovigilance.
At least 2‐4 years of experience in a similar position within the MedTech or pharma industry.
Minimum of two years' experience in regulatory affairs, regulatory submissions, filings and compliance.
Extensive experience processing documentation and controls.
2‐3 years of professional experience in GDP‐related activities within the pharmaceutical field.
At least one year of experience in pharmacovigilance and knowledge of local pharmacovigilance regulations.
Good knowledge of applicable legal and regulatory laws of the country in scope.
Good knowledge of ISO 9001, ISO 13485 and GxP regulations.
Proficiency in regulatory software, document management systems and databases.
High proficiency in MS Office, SharePoint, MS‐Teams and the ability to adapt to new technologies.
High language proficiency in English and the native language (written and spoken); other languages are an asset.
Offer for You
Individual opportunities for self‐determined career planning and professional development.
A corporate culture that allows innovative thinking to find the best solution together.
A wide network of committed people with diverse 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 promotes the effective application of the principle of equality between men and women, avoiding any type of labour discrimination based on sex, and guarantees the same opportunities for entry. We also promote diversity, rejecting discrimination based on 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.
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