Regulatory Affairs Expert

At Fresenius Medical Care, we're dedicated to improving the lives of patients with chronic kidney disease through innovative, high-quality products and treatments. Our vision—"Creating a future worth living. For patients. Worldwide. Every day."—guides everything we do. With over 125,000 people working across 3,700 dialysis centers and 39 manufacturing sites worldwide, we provide direct patient care through our Care Delivery network, develop and supply medical products, therapies, digital solutions via Care Enablement, and accelerate transformation through our FME Reignite strategy. Our values drive us:

• We Care for our patients, each other, and our communities.
• We Connect across teams and borders to deliver excellence together.
• And we Commit to doing things the right way, growing with purpose, and leading kidney care with innovation and compassion. 

As part of this commitment, Systems, Quality & Regulatory (SQR)—a global function within Care Enablement—ensures product quality and safety, regulatory compliance, and market access throughout the entire product lifecycle. The team drives quality across manufacturing and supply chain processes, manages post-market surveillance, and promotes continuous improvement, system harmonization, and sustainability. SQR also oversees Q&R data governance and delivers key product-related business services. Join our passionate team and help shape healthcare worldwide 

As a Title, your role will focus on on Drug Safety as PvRP (Pharmacovigilance), Local Drug Regulatory Affairs and Good Distribution practice (FVP/RP) in Switzerland and Austria.

RESPONSIBILITIES:

LDRA:

• Executes RA activities in line with defined procedures and processes.
• Obtain product registration dossiers from HQ Q&R and tailor them to meet country/region registration 
• requirements
• Implement processes involved with maintaining annual licenses, registrations, and listings
• Submit notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product 
• information and/or instructions for use to reflect current state of product knowledge
• Support and accelerate market access for our products in line with regulatory requirements, verticals and 
• commercial operations roadmap. Contribute to the Due diligences for in-licensing projects and to the preparation 
• of the launch for new development project for all regulatory aspects.
• Serve as the Regulatory point of contact on the assigned task(s) with local/regional management and/or at other 
• internal meetings providing the agreed global regulatory strategic recommendations and risk assessment for key 
• projects.
• Monitor, evaluate and inform key internal stakeholders about applicable national and hub regulatory 
• requirements; coordinate internal implementation and actively contribute to the development of new regulatory 
• requirements. 
• Perform all regulatory affairs activities in the hub including management of product complaints and product 
• regulatory conformity, safety, and post market systems as well as communication to applicable SysQaRa 
• functions in accordance with corporate SOPs 
• Perform based on established targets, KPIs and objectives for Q&R.

PVRP:

• Perform regular Pharmacovigilance processes and activities (including trainings). 
• Ensure that adverse events and product quality complaints are reported in compliance with corporate policies 
• and procedures.
• Lead the strategic planning and implementation of pharmacovigilance objectives in your country/region, including 
• department structure, processes, and local Health Authority policy implementation.
• Maintain the filing, storage, and archiving of safety-related documentation in accordance with company policies 
• and local requirements.
• Ensure audit / inspection readiness, coordinates, leads, and actively participates in local audits and inspections.
• Support Pharmacovigilance Agreements, when applicable.

FVP/GDP RP:

• Ensure that a Quality management system is implemented and maintained,
• Focus on the management of authorized activities (GDP) and the accuracy and quality of records.
• Ensure that initial and continuous training programs are implemented and maintained,
• Coordinate and promptly perform any recall operations for medicinal products,
• Ensure that relevant customer complaints are dealt with effectively,
• Ensure that suppliers and customers are approved,
• Approve any subcontracted activities which may impact on GDP
• Keep appropriate records of any delegated duties,
• Decide on the final disposition of returned, rejected, recalled or falsified products,
• Approve any returns to saleable stock
• Ensure that any additional requirements imposed on certain products by national law are adhered to

REQUIREMENTS:

• Scientific education such as Degree in Medicine, Pharmacy, Biology, Chemistry and/or related Engineering degree(s).
• Desirable 5 years professional experience in regulatory management of medicinal products respectively similar activity in the regulated 
• environment.
• Communicative, reliable, careful, conscientious, quality minded, detail oriented
• Regulatory and PV guidelines (EU, local)
• Switzerland: Therapeutic Products Act (TPA) Act, TPA)(Therapeutic Products Act, TPA)(Therapeutic Products Act, TPA)
• Austria: Medicinal Products Act (AMG)
• MDR/MDD
• GDP
• Microsoft Office, related MS applications
• Knowledge of German and English languague both in word and writing
• Good regulatory understanding
• Good communication skills

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