The role includes managing and supporting regulatory activities for medical devices/healthcare products. The role includes preparing and maintaining regulatory submissions and documentation, ensuring compliance with applicable regulatory requirements, coordinating product registrations and approvals, supporting regulatory audits and inspections, maintaining technical and regulatory files, monitoring changes in applicable regulations and standards, and coordinating with internal teams and regulatory authorities to ensure timely submissions and approvals.

Qualifications

- Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Life Sciences, Biomedical Engineering, or a related field.
- Relevant experience in Regulatory Affairs, preferably within the medical device, pharmaceutical,



or healthcare industry.
- Experience with regulatory submissions, product registrations, and regulatory documentation.
- Knowledge of applicable medical device regulations, standards, and regulatory requirements.
- Experience in maintaining Technical Files / regulatory dossiers and compliance documentation.
- Familiarity with ISO 13485, QMS, and other relevant regulatory standards.
- Ability to coordinate with cross-functional teams and regulatory authorities.
- Robust written and verbal communication skills.
- Good documentation and organizational skills.

📌 Regulatory Affairs Executive (New Delhi)
🏢 Intrinseque Health
📍 New Delhi