Remote EU MDR Regulatory Lead - Class I Devices

elemed; France; Remote; EUR 60,000 - 90,000; Full time

Job summary

elemed is seeking a regulatory lead for its Class I medical device portfolio under the EU MDR. The role involves owning technical documentation, labeling, UDI and EUDAMED, and ensuring proper assessment of product changes before launch.

You will drive ongoing compliance, tighten processes, and improve templates to simplify regulatory work across quality, R&D, operations and marketing. Remote in France with occasional travel and independent stakeholder management are required.

Qualifications

• Several years in medical device regulatory affairs.
• Strong working knowledge of EU MDR requirements for Class I devices.
• Experience compiling and maintaining technical documentation, labeling, UDI, and EUDAMED.
• Fluent English; French is a strong advantage.

Responsibilities

• Maintain EU MDR technical documentation and EU declarations of conformity for the Class I portfolio.
• Assess design, labeling, packaging and supplier changes for regulatory impact and provide sign-off.
• Review and approve labels, packaging artwork, IFUs and promotional material against EU MDR Annex I.
• Provide regulatory input to new product development, including pathway and market requirements outside the EU.
• Support post-market surveillance and vigilance, including PMS reports and incident reporting.
• Monitor regulatory updates and brief the business on required changes.
• Maintain regulatory SOPs and support audits; act as regulatory contact for authorities and distributors.

Skills

EU MDR

Regulatory affairs

UDI

EUDAMED

ISO 13485

Job description

elemed is seeking a regulatory lead for its Class I medical device portfolio under the EU MDR. The role involves owning technical documentation, labeling, UDI and EUDAMED, and ensuring proper assessment of product changes before launch.

You will drive ongoing compliance, tighten processes, and improve templates to simplify regulatory work across quality, R&D, operations and marketing. Remote in France with occasional travel and independent stakeholder management are required.