Quality and Regulatory Affairs Specialist - Remote

Overview

As a member of the Quality and Regulatory Affairs team in the Diagnostics department, you will support the implementation of Owkin's global quality and regulatory strategies for its In Vitro medical device software and other AI systems.

In Short

• Support the definition and execution of regulatory strategies for targeted countries.
• Coordinate and maintain regulatory related documents.
• Ensure all regulatory requirements are met throughout the development process.
• Monitor and implement new regulations and standards.
• Communicate with authorities regarding submissions and requests.
• Participate in the implementation of the quality management system.
• Contribute to the development of QMS-related documents.
• Ensure product releases and change approvals.
• Support internal and external audit activities.
• Collaborate with the team to maintain compliance.

Requirements

• Engineering, MSc or equivalent degree in quality/regulatory affairs.
• At least 5 years of experience in regulatory affairs and quality management systems.
• Mastery of medical device regulations (MDR, FDA 510(k), etc.).
• Experience with clinical trials and GxP requirements.
• Ability to work independently and in a team.
• Strong organizational and planning skills.
• Capacity for relational adaptation.
• Experience in digital pathology is preferred.
• Fluency in English; French is a plus.

Benefits

• Flexible work organization.
• Friendly and informal working environment.
• Opportunity to work with an international team.