Product Center Manager – Active Medical Devices, Digital Products

Fresenius Medical Care

Product Center Manager responsible for managing product life cycles and project execution for kidney care solutions. Collaborating across global units to ensure compliance and efficiency in medical devices.

Posted 6/11/2026full-timeBad Homburg • 🇩🇪 GermanyMid-LevelSeniorWebsite

Tech Stack

Tools & technologies

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About the role

Key responsibilities & impact

Support the Product Center In-Center organization and activities thereof, for new and mature products
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

Requirements

What you’ll need

Successfully completed bachelor’s or Master’s 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

Benefits

Comp & perks

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

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Hard Skills & Tools

project managementquality managementrisk managementmedical device regulationsdigital medical devicesmedical technologymedical informaticsISO 13485ISO 14971FDA regulations

Soft Skills

communicationcollaborationcontinuous improvementprocess optimizationcapacity managementprioritizationstakeholder engagementproblem-solvingrisk evaluationcultural development