Global Regulatory Affairs & QA Specialist - Med Devices

Chipiron; Paris; On-site; EUR 70,000 - 110,000; Full time

Job summary

Chipiron, a Paris-based startup leveraging ultra-low magnetic fields to enable affordable MRI, seeks a hands-on and strategic Regulatory Affairs & Quality Assurance Specialist to bridge development and global commercialization.

You will join our Compliance department and report to the Head of Compliance, working at the intersection of innovation, product development, clinical validation, and regulatory strategy to move fast with high patient safety standards.

Qualifications

• Medical or scientific background required.
• Minimum 3 years of QA and Regulatory Affairs experience in medical devices.
• Experience with electromedical devices is a strong plus.
• Strong knowledge of ISO 13485, FDA regulations, IEC 62304, ISO 14971, IEC 60601.

Responsibilities

• Define regulatory strategy aligned with market access for US, EU, and others.
• Plan and execute regulatory submissions and documentation for changes.
• Collaborate with R&D, Clinical, and Product teams to ensure compliance.
• Build and improve a lean QMS aligned with regulatory requirements.
• Lead Risk Management per ISO 14971.
• Review labeling and IFU documentation.
• Partner with suppliers to ensure product quality from development to production.
• Monitor evolving regulations and provide timely regulatory advice.
• Manage relationships with Regulators and Notified Bodies.
• Support Clinical Affairs activities when needed.

Skills

Quality Assurance

Regulatory Affairs

Medical devices

Regulatory strategy

Cross-functional collaboration

Communication skills

Attention to detail

Multitasking

English & French

Education

Master's degree in Quality/Regulatory Affairs for medical devices

Pharmacist

Engineering degree

Job description

Chipiron, a Paris-based startup leveraging ultra-low magnetic fields to enable affordable MRI, seeks a hands-on and strategic Regulatory Affairs & Quality Assurance Specialist to bridge development and global commercialization.

You will join our Compliance department and report to the Head of Compliance, working at the intersection of innovation, product development, clinical validation, and regulatory strategy to move fast with high patient safety standards.