Product Center Manager – Active Medical Devices, Digital Products

Role Overview

• Ensure proper project execution and manage the product lifecycle across all global markets
• Establish efficient and effective interfaces with Business Units and other involved functions within the organization (e.g., Manufacturing, Supply Chain, Systems/Quality/Regulatory) to enable rapid global market access and meet business requirements
• Oversee capacity management and prioritize Product Center activities in alignment with the strategic priorities of the respective Business Unit
• Identify, quantify and communicate quality-related project risks in product development and lifecycle management
• Ensure external regulatory information from the medical device market and regulatory authorities is understood and integrated into Fresenius processes and products
• Develop and promote a culture of continuous improvement and process optimization and share best practices across global departments and Care Enablement
• Develop, implement and monitor performance using relevant key performance indicators (KPIs)
• Monitor, analyze, report on and drive appropriate actions regarding product quality across the entire in-center Business Unit product portfolio, including active medical devices, medical device systems (ecosystems) and relevant traded goods
• Collaborate with relevant stakeholders to support the creation and maintenance of a harmonized document management structure for regulatory documents across all product groups based on a global system
• Serve as a representative in cross-functional teams as well as in governance and project review meetings
• Support risk assessments for serious product risks identified through post-market surveillance

Requirements

• Completed university degree (Bachelor’s or Master’s) in engineering or a comparable technical field, e.g., medical technology, medical informatics or natural sciences
• Solid knowledge of medical device regulations (e.g., NMPA, MDD 93/42/EEC, MDR 2017/745, MDSAP, FDA)
• Good knowledge of relevant quality and risk management standards (e.g., ISO 13485, ISO 14971, ICH Q10, EU-GMP, FDA 21 CFR §800)
• Strong project management skills
• Excellent interpersonal skills with a focus on working proactively and solution-oriented in interdisciplinary teams
• Good knowledge of medical device development processes, supplier quality management, traded goods and production transfers is an advantage
• Basic knowledge of statistical methods
• Knowledge in the field of medical devices and their clinical application
• Good knowledge of the application area of medical products, preferably dialysis, including water treatment for dialysis
• Very good German language skills and business-fluent English

Tech Stack

• TypeScript

Benefits

• Individual opportunities for self-determined career planning and professional development
• A corporate culture that allows room for innovative thinking – to jointly find the best, not the fastest, solution
• Many committed people with a wide range of skills, talents and experiences
• The advantages of a successful global group combined with the collegial culture of a medium-sized company