💼 About This Role

You'll ensure regulatory compliance and audit readiness across EMEA for medical devices. You'll manage vigilance activities and regulatory documentation for import/export. This role offers exposure to international regulatory operations in a flexible remote environment.

🎯 What You'll Do

• Ensure site-level regulatory compliance and audit readiness across EMEA
• Manage medical device vigilance activities and incident reporting
• Prepare and maintain regulatory documentation for import/export compliance
• Oversee product compliance obligations including EPR and environmental stewardship

📋 Requirements

• Proven experience in regulatory affairs within medical devices or life sciences
• Strong understanding of EU MDR, vigilance reporting, and SDS standards
• Excellent communication skills to simplify complex regulations
• High attention to detail in documentation and record management

✨ Nice to Have

• Experience with regulatory authorities or notified bodies
• Knowledge of EPR schemes and additional European languages
• Professional certifications in regulatory affairs or quality management

🎁 Benefits & Perks

• 🌍 International exposure to EMEA regulatory operations
• 🎓 Professional training and ongoing development
• 🏡 Flexible working (remote/hybrid)
• ❤️ Wellbeing resources and employee benefits
• 🤝 Inclusive work environment with equal opportunity

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Technical / Case Interview· 60 min