Regulatory Affairs Leader (Medtech)

TL;DR

Regulatory Affairs Leader (Medtech): Ensuring regulatory compliance across hirify.global F&A medical device activities throughout the product lifecycle with an accent on market entry, maintenance, and post-market surveillance. Focus on defining regulatory strategies, managing submissions like CE marking and 510(k), and interfacing with authorities, notified bodies, and stakeholders.

Location: Rennes, France

Company

Innovation-driven medical technology growth company (NYSE: ENOV) focused on orthopedics solutions for active lifestyles.

What you will do

• Ensure technical documentation compliance and ongoing market compliance for medical devices.
• Define and implement regulatory strategies, manage submissions, renewals, and export requirements.
• Conduct regulatory impact assessments for changes and contribute to post-market surveillance.
• Act as regulatory contact for internal teams, customers, distributors, notified bodies, and authorities.
• Participate in audits, manage QMS requirements (ISO 13485, 21 CFR Part 820), and support product release.

Requirements

• Location: Rennes, France
• At least 5 years in regulatory affairs for medical devices.
• Proficiency in European MDR (2017/745), CE marking, FDA processes.
• Knowledge of ISO 14971, export registrations, and QMS audits (ISO, MDSAP, FDA).
• Experience managing cross-functional strategic projects.
• Proficiency in technical English and office software.
• Strong organizational, communication, and autonomy skills.

Culture & Benefits

• Culture of continuous improvement, global talent, and innovation.
• Equal employment opportunities without discrimination.