Product Center Manager – Active Medical Devices, Digital Products

Responsibilities

• 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

• 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