Senior Operations Executive - Medical Device Regulatory

Experience : 1-2 years

Location : Rohini Sector-3, New Delhi

Company : ELT Corporate Private Limted

About us :

We are a leading consultancy providing comprehensive regulatory affairs and compliance services for medical devices across India and international markets including UAE, USA (USFDA), and Europe (CE / EU MDR) . Our mission is to help manufacturers achieve seamless product registrations and global market access with speed, accuracy, and compliance excellence.

Key Responsibilities :

• Prepare, review, and submit regulatory documentation for medical device registration and approvals in India and international markets (UAE, USA, Europe).
• Manage CE marking and EU MDR submissions , including technical file compilation and liaison with Notified Bodies.
• Handle USFDA 510(k), De Novo, and PMA submissions, including pre-submission meetings and correspondence.
• Support UAE MOHAP / SFDA / TGA / other GCC regulatory filings and country-specific dossiers.
• Stay updated with global regulatory changes and advise clients accordingly.
• Communicate with clients, regulatory authorities, and other stakeholders to ensure timely approvals.
• Review product labeling, IFUs, and promotional materials for compliance.

Required Qualifications & Experience :

What We Offer :

Skills Required

Iso 14971, Iso 13485, regulatory documentation, ce marking, Risk Management