Product Center Manager (m/f/d)

Fresenius Medical Care North America; Sankt Wendel; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading healthcare company in Saarland, Germany is seeking a Product Center Manager to oversee product lifecycle management and ensure regulatory compliance across global markets. The ideal candidate will have a Bachelor's degree in a relevant field, a minimum of five years in Regulatory or Quality Assurance for Medical Devices, and strong project management skills. As a key part of the team, you will drive continuous improvement and maintain high quality standards. Fluency in English is required.

Qualifikationen

• Minimum of five years professional experience in Regulatory or Quality Assurance for Medical Devices.
• Advanced knowledge of ISO13485, ISO14971, and EU Guidelines for GMP.
• Experience in Project Management and understanding of medical product regulations.

Aufgaben

• Enable proper projects execution and managing product life cycle across global markets.
• Monitor and report quality performance for medical devices and systems.
• Foster a culture of continuous improvement and process optimization.

Kenntnisse

Regulatory knowledge

Quality Assurance

Project Management

English fluency

Ausbildung

Bachelor degree in Technical/Engineering/Scientific field

Jobbeschreibung

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