Responsibilities
include:
1. Contribute to defining regulatory strategies and roadmaps to achieve marketing authorisation for medical devices (CE Mark in Europe and FDA approval in the United States).
2. Prepare regulatory documentation for medical devices, including in vitro diagnostics (IVDs) and medical device software.
3. Develop documentation to demonstrate compliance with technical and regulatory standards.
4. Implement and improve Quality Management Systems (QMS) by establishing procedures, work instructions, and record templates.
5. Oversee the control, planning, execution, and delivery of assigned projects, ensuring adherence to client-agreed deadlines.
6. Collaborate with and supervise the development of project documentation, following client and Medical Devices Area manager guidelines.
7. Keep clients and the Medical Devices Area manager informed about project progress, issues, and actions taken.
8. Demonstrate strong teamwork skills, working with interdisciplinary teams composed of company and customer personnel. Project management experience is a plus.
Requirements:
9. Bachelor's degree in Science, Chemical Engineering, Farmacy, Bioengineering or Biotechnology.
10. 2 years experience working in pharmaceutical and/or medical devices environment
11. Knowledge of the European Regulation / and /.
12. Knowledge of QMS standard ISO
13. Availability to travel. Customers are mostly located within Spain, but also at European countries, China or other.
14. Fluent in both Spanish and English. Other languages are highly valuable.
15. Experience as auditor is highly valuable.
16. Project Management experience is highly valuable.