💼 About This Role

You'll ensure regulatory compliance across EMEA markets, managing documentation, safety data sheets, and labeling. You'll drive audit readiness and support import/export compliance. This role offers exposure to international regulatory operations in a fast-moving 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.
• Coordinate Safety Data Sheets, hazard classifications, and labeling compliance.

📋 Requirements

• Proven experience in regulatory affairs within medical devices or life sciences.
• Strong understanding of EU Medical Device Regulation and vigilance reporting.
• Excellent organizational skills to manage multiple priorities and deadlines.
• High attention to detail in documentation and reporting.

✨ Nice to Have

• Experience with regulatory authorities or notified bodies.
• Additional European languages.
• Professional certifications in regulatory affairs or quality management.

🎁 Benefits & Perks

• 📋 Professional training and ongoing development in regulatory affairs.
• 🕒 Flexible working arrangements (remote/hybrid).
• 🌍 Exposure to international regulatory operations and cross-functional collaboration.
• 💼 Standard employee benefits package including wellbeing resources.
• 🤝 Inclusive work environment with equal opportunity principles.

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

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