Drug Quality & Regulatory Expert – Pre & PostMarket (Spain)
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Job Summary
Drug Quality & Regulatory Expert (Pre & PostMarket) - 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 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 Drug Quality & Regulatory Expert (Pre & PostMarket) - 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:
- Bachelors degree in Pharmacy Pharmaceutical Sciences Biology Biochemistry Bioengineering Health Sciences or related field
- Advanced training in Regulatory Affairs and Pharmacovigilance
- 58 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
About Company
Improve lives with a career at Fresenius Medical Care. Join a global leader in dialysis care and innovative health solutions.
