Quality Assurance Regulatory Affairs Manager

CT19; Paris; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

CT19 in Paris seeks a Regulatory Affairs & Quality Assurance Manager to shape regulatory strategy and maintain the Quality Management System across global markets.

You'll lead submissions for US and EU, collaborate with R&D, Clinical and Product teams, and ensure products meet safety, quality and compliance standards in a fast-growing startup.

Qualifications

• 3+ years’ experience in Regulatory Affairs and Quality Assurance within the medical device industry.

Responsabilités

• Define and deliver global regulatory strategies across the US, EU and other markets.
• Lead regulatory submissions and market approval activities.
• Build, maintain and continuously improve the Quality Management System (QMS).
• Lead Risk Management activities in line with ISO 14971.

Connaissances

Regulatory affairs

Quality assurance

ISO 13485

FDA regulations

Formation

Medical/science/engineering degree

Outils

Regulatory software

Description du poste

An innovative early-stage MedTech company is developing next-generation medical imaging technology with the ambition of making advanced diagnostics more accessible worldwide. With a collaborative, international team and a strong engineering culture, the business combines technical excellence with a fast-paced, entrepreneurial environment where people are encouraged to take ownership, work cross-functionally and make a real impact.

We’re looking for a Regulatory Affairs & Quality Assurance Manager to play a key role in taking innovative medical devices from development through to global commercialisation. Working closely with R&D, Clinical and Product teams, you’ll shape regulatory strategy, develop and maintain the Quality Management System, and help ensure products meet the highest standards of quality, safety and compliance.

Key responsibilities:

• Define and deliver global regulatory strategies across the US, EU and other markets.
• Lead regulatory submissions and market approval activities.
• Build, maintain and continuously improve the Quality Management System (QMS).
• Lead Risk Management activities in line with ISO 14971.
• Partner with cross-functional teams throughout product development and commercialisation.
• Manage relationships with Regulatory Authorities and Notified Bodies.
• Monitor evolving regulations and provide practical regulatory guidance across the business.

About you:

• 3+ years’ experience in Regulatory Affairs and Quality Assurance within the medical device industry.
• Strong knowledge of ISO 13485, FDA regulations, IEC 62304, ISO 14971 and IEC 60601.
• Experience supporting US market approvals.
• Medical, scientific or engineering degree (or equivalent).
• Experience with hardware/software medical devices is highly desirable.
• Fluent in English and French.
• Comfortable working in a fast-growing startup where autonomy, collaboration and problem-solving are key.