💼 About This Role

You'll ensure regulatory compliance and audit readiness for medical devices across EMEA, managing documentation, vigilance reporting, and trade compliance. You'll act as a regional subject matter expert, interpreting complex frameworks across jurisdictions to safeguard product safety. This high-impact role offers exposure to international regulatory operations and flexible working arrangements.

🎯 What You'll Do

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

📋 Requirements

• Proven experience in regulatory affairs within medical devices, pharmaceuticals, or life sciences with EMEA exposure
• Strong understanding of EU Medical Device Regulation, vigilance reporting, SDS standards, and environmental compliance
• Excellent written and verbal communication skills to simplify complex regulatory requirements
• Ability to manage multiple priorities and country-specific compliance requirements simultaneously

✨ Nice to Have

• Experience with regulatory authorities or notified bodies
• Audit or inspection exposure
• Additional European languages or professional certifications in regulatory affairs

🎁 Benefits & Perks

• 🌍 EMEA regional portfolio exposure
• 📚 Professional training and development
• 🏠 Flexible working arrangements (hybrid or remote)
• 💆 Wellbeing resources
• 🤝 Inclusive work environment

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

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