Regulatory Affairs Specialist (MedTech)

TL;DR

Regulatory Affairs Specialist (MedTech): Defining and executing regulatory strategy for France and international markets with an accent on EU MDR compliance and CE marking. Focus on managing interactions with notified bodies, supporting new product introductions, and collaborating with cross-functional teams to ensure market access.

Location: Must be based in France (Hybrid in Mouguerre or remote within France).

Company

hirify.global is an innovation-driven medical technology company dedicated to developing clinically differentiated solutions that improve patient outcomes and transform healthcare workflows.

What you will do

• Define and implement regulatory strategy for France and international markets.
• Ensure compliance with EU MDR (2017/745), CE marking, and technical documentation requirements.
• Manage interactions with notified bodies and regulatory authorities.
• Support product development and new product introduction (NPI) in collaboration with R&D.
• Provide regulatory guidance to marketing and sales teams regarding product claims.
• Liaise with the US-based regulatory affairs leadership team.

Requirements

• Bachelor’s degree in pharmacy, biomedical engineering, or a related scientific field.
• 3–4 years of experience in regulatory affairs within MedTech or medical devices.
• Fluent in English and French.
• Strong knowledge of EU MDR and regulatory authority interactions.
• Ability to influence in a matrix organization.

Culture & Benefits

• Opportunity to work in a high-growth, innovation-focused medical technology environment.
• Collaborative culture with international talent and continuous improvement initiatives.
• Hybrid work model offering flexibility between office and remote work.
• Commitment to equal opportunity and merit-based career development.