Quality Assurance Labelling Manager - EMEA - Medical Devices

Our client is a large multinational medical devices company leader in the life science industry with over 10,000 employees worldwide. The company is renowned for innovative solutions that contribute to enhancing health and well-being globally.

As a successful Quality Assurance Labelling Manager - Medical Device company you will have the following responsibilities:

Leadership activities:

• Lead the Quality Assurance Labelling teams, ensuring continuous improvement and regulatory compliance.


• Contribute to the strategic planning and direction of the Quality Assurance department.


• Oversee the training of staff in labelling procedures and regulatory requirements.


• Develop and implement labelling procedures, quality processes and quality control measures in compliance with ISO 13485.


• Work collaboratively with other departments to streamline labelling processes (Regulatory Affairs, supply chains, Business Units...).

Quality Assurance:

• Be responsible for labeling activities requests from the initiation until the approval.


• Ensure all labelling activities adhere to international regulatory standards and compliance ( ISO 13485, GDP, GMP, MDR, and IVDR regulations).


• Handle EMEA products complaints, CAPAs and deviations linked to labelling activities.


• Conduct & Coordinate regular audits and reviews to ensure labelling accuracy.


• Manage labelling documentation, maintaining records of all quality assurance activities.

As a successful Quality Assurance Labelling Manager - Medical Device company you will have the following profiles:

• A degree in Life Sciences or a related field.


• Experience in ISO 13485, GDP, GMP, and European Regulations.


• Experience in Quality Assurance, QMS and internal audits.


• Knowledge of international regulatory standards related to product labelling.


• Strong leadership skills with an ability to motivate and develop a team.


• Excellent communication and interpersonal skills.


• Fluent in Dutch & English, French being plus.