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Medical Device Regulatory & Quality Consultant, Barcelona
Client:
Advanced Resource Managers
Location:
Barcelona, United Kingdom
Job Category:
Consulting
EU work permit required:
Yes
Job Reference:
f5ac4b5dae42
Job Views:
4
Posted:
11.03.2025
Expiry Date:
25.04.2025
Job Description:
Responsibilities:
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:
1. Bachelor's degree in Science, Chemical Engineering, Pharmacy, Bioengineering or Biotechnology.
2. 2 years experience working in pharmaceutical and/or medical devices environment.
3. Knowledge of the European Regulation and QMS standards.
4. Availability to travel. Customers are mostly located within Spain, but also in European countries, China, or elsewhere.
5. Fluent in both Spanish and English. Other languages are highly valuable.
6. Experience as an auditor is highly valuable.
7. Project Management experience is highly valuable.
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