Regulatory Affairs & QA Specialist, Medical Devices

Chipiron; Paris; Hybride; EUR 60 000 - 85 000; Plein temps

Résumé du poste

Chipiron is a French startup developing ultra-low magnetic field MRI technology. We are looking for a Regulatory Affairs & Quality Assurance Specialist to guide development to global commercialization and ensure patient safety.

You will join the Compliance department, report to the Head of Compliance, and work at the intersection of innovation, product development, and regulatory strategy in a fast-paced startup environment.

Qualifications

• Medical background or equivalent (Pharmacist/Engineer/Master’s in Quality/Regulatory Affairs)
• At least 3 years in QA and RA within medical devices
• Experience with electromedical devices (hardware+software) is a plus
• Strong knowledge of medical device regs and standards incl. ISO 13485, FDA, IEC 62304, ISO 14971, IEC 60601
• Proven experience leading market approvals in the US
• Able to translate regulatory complexity into actionable guidance
• Excellent interpersonal and communication skills
• Detail-oriented with strong problem-solving skills
• Ability to manage multiple priorities in a fast-paced env.
• Fluent English and French (spoken and written)

Responsabilités

• Define regulatory strategy aligned with market access to introduce products in US, EU, and others
• Oversee regulatory submissions and documentation for products and changes
• Collaborate with R&D, Clinical, and Product teams to ensure compliance
• Build and improve a lean, scalable QMS aligned with regulatory requirements
• Lead risk management activities per ISO 14971
• Review and approve labeling and IFU
• Coordinate with R&D and suppliers to ensure product quality from development to production
• Monitor evolving regulations and provide timely regulatory advice
• Manage relationships with Regulatory Authorities and Notified Bodies
• Contribute to cross-functional initiatives including Clinical Affairs support

Connaissances

Regulatory affairs

Quality Assurance

Medical devices regulations

ISO 13485

FDA regulations

Regulatory strategy

QMS implementation

Risk management

US market approvals

Cross-functional collaboration

Formation

Pharmacist / Engineer or Master’s in Quality/Regulatory Affairs

Description du poste

Chipiron is a French startup developing ultra-low magnetic field MRI technology. We are looking for a Regulatory Affairs & Quality Assurance Specialist to guide development to global commercialization and ensure patient safety.

You will join the Compliance department, report to the Head of Compliance, and work at the intersection of innovation, product development, and regulatory strategy in a fast-paced startup environment.