Drug Quality & Regulatory Expert (Pre & Post‑Market) - Switzerland
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.
Your Responsibilities:
* Serving as the primary contact for regulatory authorities and internal stakeholders.
* Managing Regulatory Affairs, including registrations, renewals, variations, and product information updates.
* Overseeing Pharmacovigilance activities locally and ensuring compliance with global PV requirements.
* Ensuring GDP compliance throughout the supply chain, including oversight of distributors and logistics partners.
* Monitoring regulatory changes, providing regulatory intelligence, and supporting audits and inspections.
* Driving governance, GxP training, and continuous improvement initiatives.
* This position is critical to ensuring regulatory compliance, patient safety, and supply chain quality across the cluster.
Your Profile:
* Minimum BA university degree in Pharmacy, Pharmaceutical Sciences, Biochemistry, Biology, Bioengineering, Health Sciences, or similar
* Advanced training in Regulatory Affairs of medicinal products for PharmaAdvanced training in pharmacovigilance
* At least 2 - 4 years of experience in a similar position
* Minimum of 2 years’ experience in regulatory affairs in the MedTech /Pharma industry industries
* Minimum of 2 years’ experience in regulatory submissions, filings, and compliance
* Minimum of 2 years of experience in the MedTech industry
* Extensive experience in processing documentation and controls
* 2 – 3 years of professional experience in GDP‑related activities within the pharmaceutical field.
* At least 1 year experience in the pharmacovigilance and knowledge of the local regulations related to pharmacovigilance
* Good knowledge in applicable legal and regulatory laws of the countries in scope
* Good Knowledge of ISO 9001, ISO 13485, GxP regulations
* Proficiency in Regulatory Software: Familiarity with regulatory management tools and software, document management systems, and databases.
* High proficiency in MS Office applications, SharePoint, MS-Teams, etc with ability to adapt to new technologies
* High language proficiency in English and native language (written and spoken)
Other languages are an asset
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 and 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
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