We are seeking a highly motivated and detail-oriented Regulatory Digitization Coordinator to join our team in Bangalore. This role is critical in managing regulatory data, ensuring compliance, and supporting global digitization efforts.
Key Responsibilities:
✔ Regulatory Knowledge: Apply expertise in regulatory affairs (medical devices/drugs) to ensure compliance with global standards.
✔ System Management: Maintain and update regulatory data in RIMS (Regulatory Information Management System) and/or UDI systems (EUDAMED, GUDID).
✔ Data Accuracy: Prepare, validate, and analyze regulatory data to identify gaps and improvements.
✔ Global Coordination: Collaborate with international teams to review and validate regulatory data.
✔ Transition Support: Assist global teams in transitioning to RIMS/UDI systems smoothly.
Qualifications & Skills:
✅ Education: Bachelor’s degree in Regulatory Affairs, Life Sciences, Pharmacy, or related field.
✅ Experience: 3-4 years in regulatory affairs (medical devices/pharmaceuticals).
✅ Technical Skills: Proficiency in RIMS, UDI systems (EUDAMED, GUDID).
✅ Analytical Skills: Strong data analysis and problem-solving abilities.
✅ Communication: Excellent interpersonal skills for global collaboration.
✅ Detail-Oriented: Ability to manage multiple tasks with high accuracy.
Preferred Qualifications:
🔹 Experience in regulatory submissions & compliance.
🔹 Familiarity with regulatory technology tools.
🔹 Self-driven with the ability to work independently and in teams.
Why Join Us?
🌍 Global Impact: Work with international teams on critical regulatory projects.
💡 Innovation: Be at the forefront of regulatory digitization.
📈 Career Growth: Opportunities for professional development in a fast-growing industry.
