Quality & Regulatory Affairs Manager
Too late!
Job description
Scope
As QA/RA Manager you are responsible for providing leadership for the development and maintenance of Dim3 quality system for medical devices, surveillance and gap analysis of external and internal standards/regulations as well as auditing internal departments and external suppliers. Enhancing patient outcomes is at the center of everything that we do, and Quality & Regulatory compliance are critical aspects of ensuring that we deliver on our commitment to patients and healthcare professionals.
Mission
Reporting to the CEO, you work in close cooperation with all departments in the company and with our suppliers. Your main responsibilities are:
- Guarantee the quality policy of the company. Ensure that this policy is understood, implemented and maintained at all levels of the organization while complying with the appropriate external regulatory requirements (including but not limited to ISO/IEC, EU Medical Device Regulations, GDPR, FDA
and individual country requirements) - Assess the regulatory requirements for new products, manage regulatory submissions and obtain approvals in a timely manner
- Prepare and maintain Technical Files and Design Dossiers in support of CE Marking of existing and new Medical Devices
- Perform audits and provide audit support both internally and with suppliers
- Negotiate the best path forward based on available time, resources and the voice of the customer
- Report to management on the implementation and effectiveness of the quality management system and identify needs for improvement
Profile
- Bachelor or Master degree in the life science or engineering area
- Minimum of 5 years’ experience in regulated environments/regulatory agency interactions required
- Knowledge and experience of global medical devices and product regulations (e.g. EU Medical Device Regulations, ISO 13485, ISO 27001, FDA, IEC62304…) are strong assets
- Experience leading and facilitating audits
- Results and customer oriented, rigorous, autonomous and flexible
- Analytical, organized, team player, open-minded with a start-up mindset
- Fluent in French and in English. The command of any other language is an asset
- Strong oral and written
communication
Company
Dim3 develops and markets innovative eHealth software and devices to facilitate medical decisions and enhance the life of patients. We bring
Our nutrition management tools and connected products integrate automatic medical data collection, interpretation, and visualization to give healthcare professionals clear and objective information in real-time.
Dim3 is headquartered in Liege, Belgium.
Offer
- Half-time position in a motivated, lively start-up environment and contribute to making better medical decisions that enhance the life of patients
- International exposure, with significant learning and evolution opportunities
- Space for you to add your knowledge, skills
and expertise to the team, and the company as a whole, without being rigid about the way things need to be done - An attractive salary package
Your application and related information you would share will remain strictly confidential.