Graduate Trainee – Medical Device Regulatory Affairs
20 hours ago
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- & Whatsapp number
Job Types: Full-time, Permanent, Fresher
Pay: ₹250, ₹300,000.00 per year
Benefits:
- Food provided
- Paid time off
- Provident Fund
Work Location: In person
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