Day-to-day responsibilities include tracking and interpreting regulatory requirements across different regions, coordinating regulatory submissions, and supporting internal teams with timely compliance guidance. The role will collaborate closely with project management and clinical supply chain teams to assess regulatory risks, support filings for medical devices and clinical supplies, and contribute to continuous improvement of regulatory processes. The specialist will also assist in regulatory audits, maintain up-to-date records, and support training efforts on relevant regulatory standards and procedures.
Qualifications
Ability to manage and prepare high-quality regulatory documentation, including dossiers, technical files, and supporting clinical trial documents.
Solid understanding of regulatory compliance and regulatory requirements applicable to clinical development,



medical devices, and related supplies.
Experience in regulatory affairs, including interpretation of guidelines and coordination with cross-functional teams.
Proven experience with regulatory submissions to relevant authorities or ethics committees, and monitoring submission timelines.
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related field.
Familiarity with international standards and regulations (e.g., ISO, GxP, device and clinical trial regulations) is strongly preferred.
Strong analytical, organizational, and documentation skills with attention to detail and the ability to manage multiple projects.

📌 Regulatory Affairs Specialist (India)
🏢 Intrinseque Health
📍 India