Position: QA/RA Specialist – Medical Devices (MDR 2017/745)
Location: Liege (Hybrid / Remote possible)
About the Role
We are an innovative and growing organization in the medical devices sector, focused on developing clinically validated solutions that improve patient outcomes. As we prepare for the commercialization of a Class IIa medical device in Europe and international markets, we are looking for a QA/RA Specialist to lead the implementation and management of our Quality Management System (QMS) and support regulatory compliance across the product lifecycle.
This role offers the opportunity to have a direct impact in a dynamic environment and to contribute actively to the company’s growth and quality culture.
Your Responsibilities
Implement, maintain, and continuously improve the Quality Management System in compliance with ISO 13485.
Prepare, manage, and maintain regulatory documentation to ensure conformity with MDR (EU) 2017/745 for Class IIa medical devices.
Support regulatory submissions and interactions with notified bodies and other stakeholders.
Collaborate closely with R&D, clinical, and operations teams to ensure quality and regulatory compliance throughout the entire product lifecycle.
Contribute proactively to continuous improvement initiatives and quality risk management activities.
Participate in internal and external audits and support corrective and preventive actions (CAPA).
Your Profile
Experience:
Minimum 2 years of experience in Quality Assurance and/or Regulatory Affairs for medical devices, or
Relevant QA/RA training combined with at least 1 year of hands-on experience in a medical device environment.
Solid knowledge of MDR 2017/745 and ISO 13485.
Proactive, solution-oriented, and comfortable working in a fast-paced or evolving organization.
Strong organizational skills with high attention to detail.
Ability to work independently while collaborating effectively with cross-functional teams.
Fluent in English, both written and spoken, with the ability to draft quality documentation and participate in audits in a professional context.