Graduate Trainee – Medical Device Regulatory Affairs

Job Title: Graduate Trainee – Medical Device Regulatory Affairs

Company Overview

Morulaa Healthtech Pvt. Ltd. is a Chennai-based consulting firm specializing in global medical device registration and regulatory compliance. We assist medical device manufacturers, importers, and innovators worldwide in achieving market approvals by providing end-to-end support in regulatory submissions, documentation, and certification.

Position Summary

We are seeking fresh graduates (B.Tech / B.E. in Biomedical Engineering or Biotechnology) who have completed their schooling and graduation from reputed and accredited institutions.
This role is ideal for candidates who aspire to build a career in medical device regulatory affairs, documentation, and compliance consulting. Selected candidates will undergo structured training on international regulatory frameworks and quality management systems.

Key Responsibilities

• Assist in the preparation, review, and submission of technical documentation for medical device registrations.
• Support consultants in global regulatory submissions (CDSCO, US FDA, EU MDR, MHRA, TGA, ASEAN, GCC, etc.).
• Conduct regulatory research to interpret and apply country-specific compliance requirements.
• Coordinate with clients to collect technical data, reports, and product certifications.
• Help develop and maintain Standard Operating Procedures (SOPs) and quality documentation (ISO 13485, GMP).
• Maintain organized records of submissions, approvals, and regulatory correspondence.

Qualifications

• B.Tech / B.E. in Biomedical Engineering or Biotechnology.
• Must have completed schooling and graduation from reputed institutions with a consistent academic record.
• Excellent written and verbal communication skills.
• Strong attention to detail, analytical ability, and documentation skills.
• Keen interest in regulatory affairs, compliance, and healthcare technology.

Preferred Skills

• Proficiency in MS Office (Word, Excel, PowerPoint) and internet-based research.
• Ability to work collaboratively and meet strict documentation timelines.

What We Offer

• Comprehensive training in global medical device regulatory systems.
• Exposure to international registration projects and real-world regulatory workflows.
• Mentorship from senior consultants and domain experts.
• A structured career path in regulatory affairs, quality systems, or global compliance.
• A professional and learning-driven environment that values precision and integrity.

Location

Chennai, Tamil Nadu (Office-based role).

How to Apply

*To Apply:* Please send your CV to mail id- morulaa.hr@gmail.com & Whatsapp number-+91 8110076949

Job Types: Full-time, Permanent, Fresher

Pay: ₹250,000.00 - ₹300,000.00 per year

Benefits:

• Food provided
• Paid time off
• Provident Fund

Work Location: In person