Company Profile
Morulaa HealthTech is a fast-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 gap analyses, gather global regulatory intelligence, and ensure task execution aligns strictly with client service level agreements (SLAs).
What success looks like (KPIs)
- Dossier Accuracy: ≥ 95% accuracy rate on initial technical file compilations and dossier checks prior to senior review.
- SLA Adherence: 100% on-time delivery of assigned regulatory task modules within designated client timelines.
- Compliance Maintenance: Zero unresolved gaps or missing records in assigned DHFs, labeling files, or CDSCO submissions.
- Audit Readiness: 100% complete and organized digital regulatory filing maintained for swift retrieval during internal and external audits.
What you bring
- Education: Bachelor’s or Master’s degree in Biomedical Engineering, Pharmacy, Biotechnology, Life Sciences, or Medical Electronics (English-medium background preferred for strong technical writing).
- Experience: 0-1 years of internship or entry-level exposure in Medical Devices, IVDs, or Pharmaceuticals.
- Technical Knowledge: Basic foundational understanding of ISO 13485, ISO 14971, Indian MDR 2017, or US FDA/EU MDR frameworks.
- Tool Skills: High proficiency in Microsoft Office (Excel, Word) and comfortable adapting to PLM, SAP, or electronic Document Management Systems (eDMS).
- Communication & Detail: Strong technical writing, sharp proofreading abilities, high integrity with confidential data, and clear verbal communication.
Nice-to-haves
- Prior internship experience with an Indian OEM/OBL medical device manufacturer exporting to regulated markets.
- Exposure to Lean principles, process mapping, or basic quality tools.
- Student or early-career certifications (e.g., ISO 13485 internal auditor awareness).
How this role is different from a typical Regulatory Executive role
Unlike traditional administrative or static regulatory roles, you will work within a dynamic KPO delivery framework. You will gain rapid multi-market exposure, working across diverse product classifications (Class A-D / Class I-III) and international jurisdictions simultaneously rather than focusing on a single product line.
Pay: ₹200,000.00 - ₹300,000.00 per year
Benefits:
- Food provided
- Health insurance
- Leave encashment
- Paid sick time
- Provident Fund
Work Location: In person
