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Regulatory Affairs Executive at CorDx

Dubai, Dubai, United Arab Emirates -

Full Time

Start Date

Immediate

Expiry Date

10 Feb, 26

Salary

0.0

Posted On

12 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Product Registration, IVD Products, Medical Devices, Regulatory Compliance, Documentation Skills, Communication Skills, UAE Regulations, Quality Assurance, Operations Coordination, Promotional Material Review, Database Management, Post-Market Surveillance, Attention to Detail, Team Collaboration, ISO 13485

Industry

Biotechnology Research

Description

Key Responsibilities: Prepare, compile, and submit product registration dossiers for IVD products to MOHAP and other relevant authorities. Ensure timely renewal and maintenance of product licenses and regulatory approvals. Classify medical devices and IVD products according to UAE and international regulatory requirements. Review product labeling, packaging, and promotional materials for regulatory compliance. Liaise and communicate with MOHAP officers and other health authorities for registration follow-ups and clarifications. Maintain regulatory databases, documentation, and product registration records. Monitor and interpret changes in regulatory requirements and ensure company compliance. Collaborate with internal departments (Quality, Operations, Sales) to ensure all regulatory documentation supports business needs. Support importation and post-market surveillance activities as required. Bachelor’s Degree in Pharmacy, Biomedical Science, Biotechnology, or a related field. Minimum 2 years of regulatory affairs experience in IVD or medical device registration in the UAE. Proven experience in preparing and submitting product registration dossiers to MOHAP. Good understanding of UAE medical device and IVD classification, registration, and importation procedures. Familiarity with GCC and international regulatory frameworks (ISO 13485, CE marking, etc.) is an advantage. Strong organizational and documentation skills with attention to detail. Excellent communication and coordination skills with regulatory authorities. Proficiency in English (Arabic is an advantage). Based in or willing to relocate to Dubai, UAE.

Responsibilities

The Regulatory Affairs Executive is responsible for preparing and submitting product registration dossiers for IVD products to relevant authorities. They ensure compliance with regulatory requirements and maintain product licenses and approvals.