About SLTL Medical Division SLTL Medical, the name stands for superior medical products acknowledged around the globe. Owing to its high precision and consistent R&D;, it has been extending pure wellness since years. As a brand, SLTL Group’s medical division strongly commits to the value of high standard quality products. Our utmost ambition is to make the world a better place by utilizing our innovation for the betterment of human life. Kindly go through our websites mentioned below for further details. Company Website : https://www.sltlmedical.com/

Job Description
• Designation: Junior Executive/Executive
- Regulatory Affairs
• Department: RA
•

Experience:
0 to 4 Years
•

Location:
Gandhinagar
• Edu. Qualification: Any relevant Job

Responsibilities:
• Product registration and licensing activities as per:
• MDR 2017
• ISO 13485
• EU MDR regulations
• Preparation and submission of:
• Regulatory dossiers
• Technical documentation




• Product registration files
• Handling regulatory documentation management for different countries as per country-specific compliance requirements.
• Coordination and maintenance of:
• Regulatory records
• Submission tracking
• Compliance documentation
• Artwork management activities including:
• Label review
• Packaging compliance
• Regulatory text verification
• Coordination with internal departments and external regulatory authorities for approvals and submissions.
• Ensure compliance with applicable medical device regulatory standards and quality systems. Required

Skills:
• Knowledge of MDR 2017, ISO 13485, and EU MDR guidelines.
• Valuable documentation and communication skills.
• Attention to detail and regulatory compliance understanding

📌 Regulatory Affairs Executive (Gandhinagar)
🏢 SLTL Group - Medical Division
📍 Gandhinagar