Regulatory Affairs Specialist (MedTech)

Location: Hybrid in Mouguerre, Nouvelle-Aquitaine, France, or remote from France

Company

hirify.global is a medical technology company developing clinically differentiated products, services, and integrated technologies for orthopedics and active lifestyles.

What you will do

• Define and implement regulatory strategy for France and international markets.
• Ensure compliance with EU MDR (2017/745), CE marking, technical documentation, and vigilance requirements.
• Manage interactions with notified bodies and regulatory authorities.
• Support product development and new product introductions in collaboration with R&D, Quality, and commercial teams.
• Provide regulatory guidance to Marketing and Sales on claims and commercial materials.
• Monitor regulatory changes and coordinate timely implementation while liaising with US-based Regulatory Affairs leadership.

Requirements

• Bachelor’s degree in pharmacy, biomedical engineering, or a related scientific field.
• 3–4 years of regulatory affairs experience in MedTech or medical devices.
• Good knowledge of EU MDR and interactions with regulatory authorities.
• Fluent French and English required.
• Strategic, business-oriented, structured, solution-oriented, and execution-focused approach.
• Strong communication, cross-functional collaboration, and influencing skills in a matrix organization.

Culture & Benefits

• Work in an innovation-driven medical technology environment focused on patient outcomes and clinical differentiation.
• Collaborate with international R&D, Quality, commercial, and Regulatory Affairs teams.
• Hybrid or remote work arrangement available within France.
• Work within a culture of continuous improvement and innovation.