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

Medical Device Regulatory Affairs Manager

ELT Corporate Private Limited

Job Description

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