Medical device regulatory affairs manager

Company Description

ELT Corporate Private Limited is an Indian consulting company specializing in regulatory, legal, compliance, business, management, scientific, and technical services.

Job Location : - Sector-3, Rohini, Near Rohini West Metro Station, Delhi

Role Description

This is a full-time, on-site role based in Delhi for a Medical Device Regulatory Affairs Manager. The role involves ensuring compliance with local and international medical device regulatory requirements, preparing and submitting regulatory documentation, and maintaining quality system standards. The candidate will also liaise with regulatory authorities, monitor updates to regulations, and assist in the development and implementation of compliance strategies.

Qualifications

• Strong understanding of Regulatory Compliance and Regulatory Requirements
• Proficiency in Regulatory Affairs and experience with Regulatory Submissions
• Knowledge of Quality Systems and processes
• Familiarity with medical device regulations and standards (e.g., ISO 13485, MDR, FDA, etc.)
• Detail-oriented with excellent organizational and documentation skills
• Bachelor's or Master's degree in a relevant field such as Life Sciences, Pharmacy, or Engineering
• Effective communication and interpersonal skills for liaising with regulatory bodies and internal teams
• Proven ability to manage multiple projects and meet deadlines
• Experience with international regulatory submissions is a plus