Responsable Qualité anglais F/H

JR France; Les Ulis; À distance; EUR 80 000 - 120 000; Plein temps

Résumé du poste

A leading company in healthcare solutions is seeking a Head of Quality And Regulatory Affairs. This strategic leader will oversee regulatory compliance and quality for medical devices in Europe and the US. The ideal candidate will have a robust background in regulatory affairs within the medical devices industry, with a focus on innovation and compliance.

Prestations

100% health insurance coverage

Employer-covered meal vouchers

Access to well-being activities

Spacious and friendly offices in central Paris

Qualifications

• 6+ years of experience in Quality & Regulatory Affairs in the medical devices sector.
• Deep knowledge of FDA regulations and proven experience with 510(k) submissions.
• Experience in mass production and quality challenges management.

Responsabilités

• Define and execute regulatory strategies for launching new products.
• Improve production quality and reduce customer return rates.
• Maintain and optimize the ISO 13485-certified Quality Management System.

Connaissances

Quality Management

Regulatory Compliance

Technical Writing

Leadership

FDA Regulations

Formation

Engineering degree in Quality, Regulatory Affairs, or related field

Description du poste

Client:

NonStop Consulting

Location:

Paris, France (Remote work opportunities)

Job Category:

Other

EU work permit required:

Yes

Job Reference:

776917164601901056032760

Job Views:

2

Posted:

18.06.2025

Expiry Date:

02.08.2025

Job Description:

Head of Quality And Regulatory Affairs (QARA) – Dispositifs Médicaux

About the company

This innovative and growing company develops healthcare solutions aimed at improving well-being. With products combining technology and accessibility, it has already transformed the lives of hundreds of thousands of users worldwide.

Composed of passionate experts, the company operates in a dynamic environment where innovation and real impact are central to its mission. As part of its expansion, it is seeking a strategic leader to structure and oversee its Quality and Regulatory processes.

Why this position?

In response to rapid growth and new product development, the company aims to strengthen its regulatory compliance processes and ensure optimal quality levels, while maintaining an agile and pragmatic approach.

The QARA Director will be responsible for ensuring regulatory compliance and quality of medical devices marketed in Europe (Class I) and the United States (Class II – FDA 510(k)). Their role will be key in managing regulatory submissions, maintaining ISO 13485 certification, and optimizing manufacturing processes for smooth and compliant production.

Responsibilities

• Define and execute regulatory strategies for launching new products, ensuring FDA (510(k)), CE (Class I), and ISO 13485 compliance.
• Improve production quality and reduce customer return rates through post-market surveillance and CAPA processes.
• Maintain and optimize the ISO 13485-certified Quality Management System, balancing efficiency and compliance.
• Collaborate with R&D, Manufacturing, and Supply Chain teams to integrate quality and regulatory requirements from design to production.
• Lead and structure the QARA team, fostering a culture of compliance without unnecessary administrative burden.

Candidate profile

Technical skills

• Engineering degree in Quality, Regulatory Affairs, or related field.
• 6+ years of experience in Quality & Regulatory Affairs in the medical devices sector, including 3+ years in management.
• Deep knowledge of FDA regulations and proven experience with 510(k) submissions.
• Experience in mass production and quality challenges management.
• Proficiency in English (written and spoken), with excellent technical writing skills.

Additional assets

• Experience with connected medical devices.
• Knowledge of international regulations outside Europe.

What the company offers

• Real impact: directly contributing to improving many lives worldwide.
• Autonomy and responsibilities: a key role in Quality and Regulatory Affairs management.
• Dynamic environment: a caring and committed team combining innovation and high standards.
• Other benefits: 100% health insurance coverage, employer-covered meal vouchers, access to well-being activities, spacious and friendly offices in central Paris.

Please note: If you are not a passport holder of the country for the vacancy, you might need a work permit. Check our Blog for more information.

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