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 seasoned Senior Regulatory Affairs Executive / Lead (5+ years of experience) to drive high-caliber global regulatory strategies and deliverables. In this role, you will take full ownership of complex technical documentation and end-to-end global submission workflows across international markets (USA, EU, Japan, Australia) and the Indian CDSCO framework. Designed as a key leadership and execution position, you will oversee compliance strategies for Class A through Class D Medical Devices and IVDs, mentoring junior team members and converting deep regulatory expertise into client-facing, audit-ready deliverables.

What you'll do

- Global Regulatory Submissions & Strategy: Lead the drafting, compilation, review, and strategic submission of high-quality regulatory dossiers, including EU MDR/IVDR Technical Files, FDA 510(k)/PMA, TGA, UKCA, and JPAL/PMDA documentation. Drive compliance updates for Risk Management (ISO 14971), Clinical/Performance Evaluation Reports (CER/PER), Biological Evaluations (ISO 10993), Design History Files (DHF), labeling, UDI, and IFU frameworks.
- Indian Market Compliance (CDSCO): Direct end-to-end submissions for Class A, B, C, and D devices under the Indian Medical Device Rules (MDR) 2017.



Oversee the compilation of complex Device Master Files (DMF) and Plant Master Files (PMF) for CDSCO approvals, managing key liaison communications with regulatory authorities.
- Audit, Quality & Post-Market Operations: Lead regulatory defense and support quality teams during Notified Body audits, FDA inspections, and ISO 13485/MDSAP programs. Oversee Post-Market Surveillance (PMS), Periodic Safety Update Reports (PSUR), vigilance reporting, and CAPA/DPA execution.
- Delivery Leadership & Intelligence: Conduct comprehensive regulatory gap analyses, monitor global regulatory changes, guide team members, and ensure high-volume execution aligns strictly with client Service Level Agreements (SLAs).

What success looks like (KPIs)

- Dossier First-Pass Yield: ≥ 98% first-time approval and accuracy rate on technical files, dossiers, and authority submissions.
- SLA & Timeline Adherence: 100% on-time delivery of client regulatory projects and key milestones.
- Compliance & Audit Readiness: Zero major non-conformances or unresolved gaps in managed DHFs, labeling, or CDSCO filings during external/internal audits.
- Client Satisfaction & Team Output: High audit readiness and smooth delivery across multi-market client engagements.

What you bring

- Education: Bachelor’s or Master’s degree in Biomedical Engineering, Pharmacy,



Biotechnology, Life Sciences, or Medical Electronics.
- Experience: 5+ years of hands-on experience in Regulatory Affairs within Medical Devices, IVDs, or combination products, with proven expertise handling multi-market submissions.
- Technical Knowledge: Deep working mastery of ISO 13485, ISO 14971, Indian MDR 2017, US FDA 510(k), EU MDR (2017/745), and IVDR (2017/746) frameworks.
- Tool Skills: Advanced proficiency in Microsoft Office (Excel, Word) and extensive hands-on experience using eDMS, PLM, or SAP platforms.
- Communication & Leadership: Exceptional technical writing, sharp proofreading, team mentorship abilities, and explicit executive-level client communication skills.

Nice-to-haves

- Experience working with an Indian OEM/OBL medical device manufacturer exporting to regulated global markets.
- Certified ISO 13485 Lead/Internal Auditor certification or RAC (Regulatory Affairs Certification).
- Experience with Lean principles, workflow optimization, or managing regulatory tasks within KPO/consulting setups.

How this role is different from a typical Regulatory role Unlike traditional static or single-product regulatory positions, you will lead within a dynamic KPO and tech-driven delivery framework. You will oversee multi-market strategies across diverse product classifications (Class A-D / Class I-III) simultaneously, driving multi-jurisdictional compliance for global healthcare leaders.

Pay: ₹300,000.00 - ₹500,000.00 per year

Benefits

- Food provided
- Health insurance
- Leave encashment
- Paid sick time
- Provident Fund

Work Location: In person

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