Product Center Manager Active Medical Devices & Digital Products (mfd)

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 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!

In your role you will support the Product Center In-Center organization and activities thereof for new and mature products enabling proper and timely project execution and managing product life cycle across all global markets with the target to constantly deliver safe efficient and compliant products of the highest quality standard. The role ensures timely preparation and submission of deliverables needed for products implementation in different markets supporting marketing and regulatory strategy and provide substantial support and coordination for products life cycle auditing activities of external bodies.

Your tasks

• Enabling proper projects execution and managing products life cycle across all global markets
• Establish efficient and effective interfaces with Business Units and other involved units across the organization (e.g. Manufacturing Supply Chain Systems/Quality /Regulatory) to assure fast global market access and business needs
• Oversee the capacity management and prioritization of Product Center activities in line with the In Business Unit strategic priorities
• Identify quantify and communicate quality related project risks within new product developments and lifecycle management
• Ensure external regulatory intelligence from the medical device market and regulatory authorities is understood and translated into Fresenius processes and products as required
• Communicate/collaborate to ensure Product Center is a trusted partner with all relevant functions within Fresenius Medical Care to achieve effective Regulatory compliance and patient/product outcomes
• Develop and foster a culture of continuous improvement and process optimization sharing best practices across global departments and Care Enablement
• Develop deploy and monitor performance to applicable Key Performance Indicators
• Monitor report and react to quality performance covering the full In Center Business Unit product portfolio active medical devices as well as medical device systems (Ecosystem) including Digital products and services (as far as applicable)
• Work with relevant stakeholders in the organization to support the creation and maintenance of a harmonized document management structure for regulatory relevant documents across all products groups based on a global system
• Quality representative in cross functional teams and governance and project review meetings
• Support Risk Evaluation in case of severe Product Risks identified in Post Market Surveillance

Your profile

• Successfully completed bachelors or Masters degree in engineering or a comparable technical program e.g. medical technology medical informatics or natural sciences
• Advanced knowledge of regulations for medical devices (NMPA MDD 93/42/EEC MDR 745/2017 MDSAP FDA etc.)
• Advanced knowledge of applicable quality management and risk management standards (e.g. ISO 13485 ISO 14971 ICH Q10 EU GMP FDA)
• Advanced knowledge in the field of digital medical devices (Software as a Medical Device)
• Advanced project management skills
• Knowledge of medical device development processes supplier quality handling traded goods and production transfer are an asset
• Good knowledge in medical products field application preferably dialysis and related therapies
• Good knowledge of German and fluency in English

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