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/
- 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
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