Regulatory Affairs Executive

SLTL Group - Medical Division

About SLTL Medical Division

SLTL Medical is recognized globally for its superior medical products. The division is committed to high-standard quality products, utilizing innovation for the betterment of human life.

Job Description

• Designation: Junior Executive/Executive - Regulatory Affairs
• Department: RA
• Location: Gandhinagar
• Educational Qualification: Any relevant

Key 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.

Requirements & Tech Stack

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