Medical Device Regulatory & Quality Consultant in Barcelona

Advanced Resource Managers are currently supporting a Quality Assurance Consultancy in Barcelona, Spain in their search for a Medical Device Regulatory and Quality Consultant on a permanent basis. This position is based onsite in Barcelona for at least 3 days per week, 2 days remote working.

Responsibilities include:

• 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).
• Prepare regulatory documentation for medical devices, including in vitro diagnostics (IVDs) and medical device software.
• Develop documentation to demonstrate compliance with technical and regulatory standards.
• Implement and improve Quality Management Systems (QMS) by establishing procedures, work instructions, and record templates.
• Oversee the control, planning, execution, and delivery of assigned projects, ensuring adherence to client-agreed deadlines.
• Collaborate with and supervise the development of project documentation, following client and Medical Devices Area manager guidelines.
• Keep clients and the Medical Devices Area manager informed about project progress, issues, and actions taken.
• Demonstrate strong teamwork skills, working with interdisciplinary teams composed of company and customer personnel. Project management experience is a plus.

Requirements:

• Bachelor's degree in Science, Chemical Engineering, Farmacy, Bioengineering or Biotechnology.
• 2 years experience working in pharmaceutical and/or medical devices environment
• Knowledge of the European Regulation 2017/745 and 2017/746.
• Knowledge of QMS standard ISO 13485
• Availability to travel. Customers are mostly located within Spain, but also at European countries, China or other.
• Fluent in both Spanish and English. Other languages are highly valuable.
• Experience as auditor is highly valuable.
• Project Management experience is highly valuable.

Disclaimer:

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission.