Quality & Regulatory Specialist

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 

The holder of this position is a member of Q&R Hub EMEA North especially responsible to:

• Implementation and maintenance of local Quality Management System for Medical Devices and medicinal products according to EU and local regulations in cooperation with the Nordic and BeNeLux Quality Team.
• Establishing, implementation, maintenance and improvement of processes. Align processes cross-functionally and within the Nordics & Benelux to create a common, logical and efficient flow to ease the role's performance.

RESPONSIBILITIES:

• Implementation and maintenance of the local Quality Management System in cooperation with the Nordic and BeNeLux Quality Team. 
• If applicable, modification / adaption of Corporate requirements according to national / local needs.
• If applicable, creation of local instructions according to national requirements.
• Establishing, implementation, maintenance and improvement of processes.
• Tracking of CAPA.
• Maintenance of a documentation management system.
• Assist Quality Manager and Responsible Person (RP) as contact partner for audits by the Notified Body, Health Authorities or Corporate functions.
• Contact partner for information to be given to national competent Authorities (FSCA, Recall, etc.) in cooperation with Nordic Quality Team and RP.
• Tracking, follow up and closure of complaints via QTrack. Share applicable information with Quality Manager and RP.
• Preparation of Management Review in cooperation with the Nordic Quality Team.
• Qualification and maintenance of critical suppliers, in cooperation with Procurement, Nordic Quality Team and RP.
• Training activities, e.g. Quality introduction for new employees.
• Performance of self-inspections/internal audits in cooperation with Nordic Quality Team.
• Monitoring of national requirements for medical devices.

REQUIREMENTS:

• Scientific education such as Degree in Medicine, Pharmacy, Biology, Chemistry or similar.
• 2- 5 years of professional experience in quality management of medical devices or medicinal products respectively similar activity in the regulated environment.
• Communicative, reliable, careful, conscientious, quality minded, detail oriented, solution-oriented, proactive, analytical and problem-solving skills;
• Highly professional attitude characterized by a result, quality, patient and customer oriented working style.
• Functional knowledge of Structure of Quality Management System, ISO 9001 / ISO 13485, MDR, Good Distribution Practice (GDP)
• Microsoft Office, QTrak, skills
• Fluent Swedish and English
• 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

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