* Proven experience in quality management and regulatory affairs.
* Excellent knowledge of regulatory standards in the healthcare industry.
About Our Client
Our client is a medium-sized organization within the life science industry, operating within the healthcare sector. With a strong reputation for innovation, they are committed to delivering high-quality solutions that drive excellence in patient care.
Job Description
As the Quality and Regulatory lead, your responsibilities include:
* Lead National Oversight: Manage SHS Quality and Regulatory (QT) activities for Belgium and Luxembourg.
* Monitoring Regulatory: Represents SHS Country Organization in local country QT (QM and RA) community and related activities as well as monitoring the regulatory environment.
* Maintain Government Relations: Act as main contact with authorities for Medical Devices/IVD products.
* Manage Licensing: Ensure all necessary business and import licenses are valid.
* Implement QMS: Maintain and enforce the Quality Management System.
* Support Corrective Actions: Assist with safety corrective actions and post-market surveillance.
* Maintain Certifications: Oversee ISO 9001/13485 certification and quality system improvements.
* Ensure Supplier Compliance: Verify suppliers meet regulatory and compliance requirements and manage complaints.
* Lead Performance System: Drive continuous improvement, efficiency, and quality performance metrics.
The Successful Applicant
A successful Quality and Regulatory Lead should have:
* A strong educational background in Life Science, or a related field.
* Proven experience in quality management and regulatory affairs within the healthcare sector.
* Excellent knowledge of regulatory standards in the life science/healthcare industry.
* Leadership skills and the ability to mentor a team.
* Strong communication skills and the ability to liaise with regulatory bodies.
What's on Offer
Our client offers you:
* An estimated annual salary of EUR 85,500 - 104,500.
* A comprehensive benefits package.
* A supportive work environment that encourages professional growth.
* Opportunities to make a real impact in the life science industry and healthcare sector.
Take the next step in your career and become a leader in quality and regulatory affairs. Apply today for this exciting opportunity in Groot-Bijgaarden. #J-18808-Ljbffr