Regulatory Affairs Executive

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: RAExperience: 0 to 4 Years

Location: GandhinagarEdu.

Qualification: Any relevant

Job Responsibilities

Product registration and licensing activities as per:MDR 2017ISO 13485EU MDR regulationsPreparation and submission of:Regulatory dossiersTechnical documentationProduct registration filesHandling regulatory documentation management for different countries as per country-specific compliance requirements.Coordination and maintenance of:Regulatory recordsSubmission trackingCompliance documentationArtwork management activities including:Label reviewPackaging complianceRegulatory text verificationCoordination 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.Good documentation and communication skills.Attention to detail and regulatory compliance understanding