- Where
- Suzhou, Jiangsu, China
- Level
- Mid
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