Summary of Key Responsibilities and Function
The purpose of this role is to provide operational direction and leadership for driving the successful implementation of one aligned quality management system for our commercial organisation in the region, and then maintain and improve the system. Part of the responsibilities is also to represent the entities in any contact with local authorities responsible for regulation and surveillance of product safety, where applicable.
The person in this role will be responsible for the quality and regulatory compliance activates and lead a cluster of countries; France and Belgium. This function will report directly into the commercial Cluster Top Manager for France and Belgium. Part of the role is to coach and lead the local team, dedicated to quality and regulatory activities, in France and Belgium.
This role will have a functional report line into the Lead Quality and Regulatory Representative Europe.
Our commercial organisations are managing sales and marketing, distribution, import, warehousing, customer services and field service operations for diagnostics medical device products and related industries. The quality management system is based on the requirements of ISO 13485 and ISO 9001.
- External and internal audits.
- Quality System Management
- Regulatory Affairs and Post Market Surveillance
- Non Conformities and Corrective Actions
- Management Review and Quality Metrics
- Trainings on quality system and procedures