Regulatory Affairs Manager

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

This is an established medical device manufacturer with a broad portfolio of Class I devices, sold across Europe and into international markets. Products are made and distributed through several sites, and over the years each one has built its own way of recording product information.

The role is fully remote within France, with occasional travel when needed. You will work closely with quality, R&D, operations and marketing, and report into the Head of Regulatory Affairs.

The Opportunity

You will be the regulatory lead for a Class I portfolio under the EU MDR, owning technical documentation, labelling, UDI and EUDAMED, and making sure every product change and launch is assessed properly before it goes ahead.

The work is a mix of ongoing compliance and improvement. Alongside keeping files current and signing off changes, you will have room to tighten processes, improve templates and make regulatory easier for the rest of the business to work with. Someone who is organised, confident with stakeholders and happy to work independently will do well here.

What You'll Be Doing

• Maintain EU MDR technical documentation and EU declarations of conformity for the Class I portfolio, keeping files current as products and standards change.
• Assess design, labelling, packaging and supplier changes for regulatory impact, and provide regulatory sign-off through change control.
• Review and approve labels, packaging artwork, instructions for use (IFUs) and promotional material against EU MDR Annex I
• Provide regulatory input to new product development, including classification, applicable standards, the regulatory pathway and requirements for markets outside the EU.
• Support post-market surveillance and vigilance, including PMS reports, trend reviews, incident reporting to competent authorities and field safety corrective actions.
• Monitor regulatory and standards updates, assess their impact on the portfolio and brief the business on what needs to change.
• Maintain regulatory SOPs, support internal and external audits, and act as a point of contact for competent authorities and distributors on regulatory matters.

What We're Looking For

• Several years in medical device regulatory affairs, with strong working knowledge of the EU MDR and its requirements for Class I devices.
• Experience compiling and maintaining technical documentation, and assessing changes for regulatory impact.
• Hands-on experience with UDI and EUDAMED device registration.
• Familiarity with ISO 13485, ISO 14971 and post-market surveillance and vigilance processes.
• The confidence to work independently in a remote role and influence colleagues across quality, R&D, operations and marketing.
• Fluent English. French is a strong advantage.
• PRRC eligibility, or experience with other markets such as FDA or UKCA, is an advantage.