Quality & Regulatory Manager — Health AI Diagnostics

Spotlab; Madrid; Híbrido; EUR 40 000 - 80 000; Tempo integral

Resumo da oferta

An innovative startup is seeking a Regulatory Affairs Specialist to help navigate the complex landscape of medical device regulations. In this pivotal role, you will contribute to the regulatory strategy for groundbreaking AI products that enhance medical diagnostics. You will ensure compliance with EU regulations while collaborating with a diverse team of experts. This position offers a unique opportunity to make a real impact in healthcare, bringing pioneering AI solutions to market that improve patient outcomes. If you are passionate about quality and regulatory affairs and thrive in a dynamic environment, this role is perfect for you.

Qualificações

• 2+ years in regulatory affairs and quality management for medical devices.
• Strong understanding of EU MDR and IVDR regulations.

Responsabilidades

• Contribute to regulatory strategy for AI products in the medical sector.
• Support CE Marking process for In Vitro Medical Devices.

Conhecimentos

Regulatory Affairs

Quality Management

Analytical Skills

Communication Skills

Attention to Detail

AI Systems Regulation

Team Collaboration

Formação académica

University degree in Engineering

University degree in Medicine

University degree in Pharmacy

University degree in Law

Relevant scientific discipline

Descrição da oferta de emprego

An innovative startup is seeking a Regulatory Affairs Specialist to help navigate the complex landscape of medical device regulations. In this pivotal role, you will contribute to the regulatory strategy for groundbreaking AI products that enhance medical diagnostics. You will ensure compliance with EU regulations while collaborating with a diverse team of experts. This position offers a unique opportunity to make a real impact in healthcare, bringing pioneering AI solutions to market that improve patient outcomes. If you are passionate about quality and regulatory affairs and thrive in a dynamic environment, this role is perfect for you.