Senior Raqa Engineer

Summary

Join Owkin's Quality and Regulatory Affairs team as a key contributor to the implementation of global quality and regulatory strategies for In Vitro medical device software and AI systems. You will support the definition and execution of regulatory strategies, coordinate regulatory documents, ensure compliance throughout the development process, and participate in quality management system maintenance. This role requires a strong background in regulatory affairs and quality management systems for medical devices, along with experience in relevant standards and regulations. The position is based in Paris or Nantes, or remotely in France. Owkin offers a flexible work organization and a friendly working environment within an international team.

Requirements

• Engineering, MSc or equivalent degree in quality / regulatory affairs
• At least 5 years of successful experience within regulatory affairs and in quality management systems relating to medical devices/in vitro diagnostic medical software devices and/or clinical studies/trials
• You master the regulations for medical devices (MDR and FDA 510(k)/De novo/PMA minimum, IVDD/IVDR is a plus), ISO 13485 QMS, medical devices standards (ISO 14971, ISO 15223-1, IEC 62366-1,...) and medical device software standards (IEC 62304 / IEC 82304-1, IEC 81001-5-1,...)
• You have experience on clinical trials / clinical studies standards and regulations (GxP requirements, GCP/GLP, ICH E6 R3, FDA IDE, ISO 20916 or ISO 14155)
• You are able to work independently and as part of a team, in a fast-paced environment
• You have organizational and planning skills, including being action oriented and problem solving
• You have great capacity for relational adaptation which will allow you to integrate quickly into a young dynamic team
• Fluent in English

Responsibilities

• Support the definition and execution of regulatory strategies in line with the targeted countries and priorities (at least for the European Union and the USA) and aligned with the company's objectives
• Coordinate and support the implementation and maintenance of regulatory related documents (Technical documentation, documents to be submitted to regulatory authorities, change requests etc.)
• Support the development team to ensure all regulatory requirements are met throughout the development process and post market activities, including leading the risk analysis of the product
• Ensure the identification and monitoring process, evaluation of impact, and implementation of new regulations, standards and guidelines
• Be one of the contacts for communication with authorities (request, submission, vigilance)
• Participate to the regulatory review of promotional materials process improvement and implementation
• Participate in the implementation and maintenance of the quality management system in accordance with the applicable regulations (ISO 13485, QMSR, AI act…) including the management of non-conformities, CAPA or complaints analysis
• Contribute to the development of procedures, work instructions and other documents related to the QMS
• Ensure product releases and change approval
• Pilot internal and external audits activities
• Support the qualification of tools and suppliers
• Collaborate with the entire team to maintain good practices and compliance

Preferred Qualifications

• Experience in digital pathology
• French is a plus

Benefits

• Flexible work organization
• Friendly and informal working environment
• Opportunity to work with an international team with high technical and scientific backgrounds