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:
- Bachelor's / Master's degree in Biomedical Engineering, Pharmacy, Life Sciences, or related discipline.
- 1-2 years of experience in Regulatory Affairs for medical devices (mandatory).
- Proven experience in global submissions USFDA, EU MDR, CE marking, and UAE MOHAP or other GCC markets.
- Strong understanding of ISO 13485, ISO 14971 (Risk Management), and GMP requirements.
- Excellent written and verbal communication skills in English.
- Proactive, detail-oriented, and able to handle multiple projects simultaneously.
What We Offer:
- Opportunity to work on diverse international projects.
- Exposure to multi-country regulatory frameworks.
- Professional growth in a fast-expanding consultancy.
- Supportive and flexible work environment.
