Quality & Regulatory Specialist

• 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 Enablementensures 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 roles 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 13485MDR 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