Regulatory Affairs Specialist

About Bonn Medical Industries

Bonn Medical Industries is a Saudi-based manufacturer specializing in healthcare products, cosmetics, and personal care solutions. The company develops and manufactures a growing portfolio of products serving healthcare providers, institutions, and consumers across the region.

As part of our continued growth, we are looking for an experienced Regulatory Affairs Specialist to support product registrations, regulatory compliance, and market access activities across our healthcare, medical device, food supplement, and cosmetic product lines.

Role Overview

The Regulatory Affairs Specialist will be responsible for managing regulatory submissions, ensuring compliance with SFDA requirements, and supporting the successful registration and maintenance of the company's products in the Saudi market.

The ideal candidate should have strong experience in regulatory documentation, product registration processes, and coordination with cross-functional teams including R&D, Quality, and Production.

Key ResponsibilitiesProduct Registration & Regulatory Submissions

• Manage registration activities for healthcare products, medical devices, food supplements, and cosmetics.
• Prepare, review, and submit regulatory documentation according to SFDA requirements.
• Follow up on registration applications and regulatory approvals.

Regulatory Documentation

• Prepare and maintain CTD dossiers, Medical Device Technical Files, Technical Data Sheets (TDS), and other required regulatory documents.
• Ensure regulatory files remain updated and compliant with current requirements.
• Maintain proper documentation and records for audits and inspections.

Regulatory Compliance

• Monitor updates to SFDA regulations, guidelines, and requirements.
• Assess regulatory impacts on existing and new products.
• Support implementation of regulatory requirements across relevant departments.

Cross-Functional Coordination

• Coordinate with R&D, Quality Control, Production, and other departments regarding product registration and compliance activities.
• Follow up on testing requirements, documentation requests, and regulatory timelines.
• Support product launch readiness from a regulatory perspective.

Requirements

• Bachelor's degree in Pharmacy or a related scientific field.
• 3–5 years of experience in Regulatory Affairs.
• Strong knowledge of SFDA regulations and registration processes.
• Experience preparing CTD dossiers, Medical Device Technical Files, and cosmetic registration documentation.
• Strong attention to detail and documentation skills.
• Professional proficiency in English and Arabic.

Preferred Qualifications

• Experience within pharmaceutical, healthcare, cosmetics, medical device, or food supplement industries.
• Familiarity with GMP, ISO standards, and quality management systems.
• Experience handling multiple product categories simultaneously.
• Strong project coordination and communication skills.

Work Conditions

• Full-time position
• Relocate to Saudi Arabia

What We're Looking For

We are looking for a proactive and detail-oriented regulatory professional who can ensure compliance, support product registrations, and contribute to the successful growth of Bonn Medical Industries across multiple regulated product categories.