Company Profile

Morulaa HealthTech is a rapid-growing technology company building AI-driven regulatory and compliance solutions, helping over 500+ global medical device and IVD manufacturers navigate complex regulatory pathways into India, the EU, the USA, and ASEAN markets. Our platforms help organizations automate document-heavy workflows.

Why this role exists

We are expanding our Global Regulatory Division and seeking a driven, entry-level Regulatory Affairs Executive (0-1 years of experience) to support high-caliber regulatory services. In this role, you will be deeply involved in hands-on technical documentation, learning global submission workflows across international markets (USA, EU, Japan, Australia) and the Indian CDSCO framework. Designed as a high-growth career springboard, this position offers direct exposure to Class A through Class D Medical Device and IVD compliance strategies, converting foundational academic knowledge into impactful, audit-ready deliverables.

What you'll do
- Global Regulatory Submissions & Documentation: Assist in drafting, compiling,



and maintaining high-quality regulatory dossiers, including EU MDR/IVDR Technical Files, FDA 510(k), TGA, UKCA, and JPAL/PMDA documentation. Support file updates for Risk Management (ISO 14971), Clinical/Performance Evaluation Reports (CER/PER), Biological Evaluations (ISO 10993), Design History Files (DHF), labeling, UDI, and IFU compliance.
- Indian Market Compliance (CDSCO): Support end-to-end submissions for Class A, B, C, and D devices under the Indian Medical Device Rules (MDR) 2017. Assist in compiling Device Master Files (DMF) and Plant Master Files (PMF) for CDSCO approvals and track liaison communications with regulatory authorities.
- Audit, Quality & Post-Market Support: Assist quality teams during Notified Body audits, FDA inspections, and ISO 13485/MDSAP programs. Help log Post-Market Surveillance (PMS), PSUR, vigilance, and CAPA/DPA records.
- Delivery & Intelligence: Perform basic

📌 Regulatory Affairs Executive (Perungudi)
🏢 Morulaa HealthTech
📍 Perungudi