Product Center Manager

In your role as Product Center Manager (m/f/d) you support the Product Center & Risk Management 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 interaction, 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 assignment:

• Enabling proper projects execution and managing products life cycle across all global markets
• Establish efficient and effective interfaces to assure fast global market access and business needs
• Oversee the capacity/competence management and prioritization of Product Center activities in line with the Value Stream strategic priorities
• Request pro-actively applicable SQR resources and competences according an established Value Stream product roadmap
• Trigger timely involvements of relevant functions for new product development and major design changes
• Identify, quantify and communicate quality related project risks within new product developments and lifecycle management
• Develop, deploy and monitor performance to applicable KPIs (Key Performance Indicators)
• Ensure new external regulatory intelligence, from the medical device market and regulatory authorities, is understood, forwarded and translated for the Value Stream needs (into applicable processes and products as required)
• Communicate/collaborate to ensure the Product Center is a trusted partner with all relevant functions to achieve effective regulatory compliance
• Develop and foster a culture of continuous improvement and process optimization, sharing best practices
• Monitor, report and react to quality performance, covering the full Value Stream product portfolio, active and non-active medical devices as well as medical device systems (Ecosystem) including Digital products and services (as far as applicable)

Your profile:

• Bachelor degree with a Technical/Engineering/Scientific background
• Minimum of five years professional experience in the field of Regulatory or Quality Assurance Medical Devices / Medicinal Products
• Knowledge in the field of development and/or manufacture and control of Medical Devices and Medicinal Products
• Advanced knowledge of applicable quality management and of risk management standards (e.g. ISO13485, ISO14971, EU Guidelines for GMP, IFDA 21 CDR §820.250, etc.)
• Advanced knowledge of medical device regulations (MDD 93/42/EEC, MDR 2017/745, etc.)
• Experience in Project Management
• Knowledge of Quality Management System requirements and main related processes
• Knowledge of medical products field and application, preferably dialysis and related therapies
• Fluent in English

About Us

Creating a future worth living. For patients. Worldwide. Every day.

Fresenius Medical Care is the world's leading provider of products and services for individuals with kidney disease of which approximately 4.5 million patients worldwide regularly undergo dialysis treatment. United by a shared purpose of creating a future worth living for chronically and critically ill people, we care for around 292,000 dialysis patients around the globe. In addition, we operate around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables.

We aim to continuously improve our patients’ quality of life by offering them high-quality products as well as innovative technologies and treatment concepts.