Are you passionate about medical device regulatory affairs and global compliance?
ELT Corporate Private Limited, a leading regulatory consultancy based in Rohini Sector-3, New Delhi, is hiring for the role of Operations Executive – Medical Device Regulatory. This position offers hands-on experience with global submissions including USFDA 510(k), CE marking, and EU MDR documentation, providing a unique opportunity to work on international regulatory frameworks.
About ELT Corporate Pvt Ltd
ELT Corporate Pvt Ltd is a trusted consultancy delivering regulatory affairs and compliance services for medical devices across India, the UAE, USA, and Europe. The company specializes in product registration, technical file compilation, and global market access for medical device manufacturers.
Their mission: To simplify and accelerate regulatory pathways through expertise, precision, and compliance excellence.
Key Responsibilities
As an Operations Executive – Medical Device Regulatory, your core duties will include:
- Preparing, reviewing, and submitting regulatory documentation for medical device registration in India and abroad.
- Managing CE marking and EU MDR submissions, including technical file preparation and communication with Notified Bodies.
- Handling USFDA 510(k), De Novo, and PMA submissions, including coordination of pre-submission meetings.
- Supporting UAE MOHAP, SFDA, TGA, and GCC regulatory filings.
- Monitoring global regulatory changes and advising clients on compliance updates.
- Reviewing product labeling, IFUs, and promotional content for adherence to applicable regulations.
Required Qualifications & Experience
- Bachelor’s or Master’s degree in Biomedical Engineering, Pharmacy, Life Sciences, or a related discipline.
- 1–2 years of proven experience in medical device regulatory affairs (mandatory).
- Strong knowledge of ISO 13485, ISO 14971 (Risk Management), and GMP standards.
- Hands-on exposure to USFDA, EU MDR, CE, and UAE MOHAP submissions.
- Excellent communication, analytical, and multitasking skills.
What You’ll Gain
- Work on diverse international medical device projects.
- Gain exposure to multi-country regulatory frameworks.
- Experience career growth within a rapidly expanding consultancy.
- Be part of a supportive and collaborative work culture.
Location & Experience
- Location: Rohini Sector-3, New Delhi
- Experience Required: 1–2 years
- Job Type: Full-time | On-site
How to Apply
