Senior Regulatory Specialist

18 hours ago

Riyadh, Ar Riyāḑ, Saudi Arabia Tamkeen Almutahida I TABSCO Full time

‏⁦

Position: Senior Regulatory Specialist

Location: Riyadh

Department: Regulatory Affairs

Employment Type: Full-time

About the Role

We are seeking an experienced Senior Regulatory Specialist to lead and support regulatory activities, ensure full compliance with local and international regulations specifically the SFDA, and drive successful market access for the products. The ideal candidate has strong expertise in regulatory submissions, medical device, IVD registrations, and communication with the SFDA.

Key Responsibilities

Lead and manage regulatory submissions, approvals, renewals, and variations.

Prepare, review, and submit regulatory dossiers in line with the SFDA.

Ensure full compliance with applicable laws, guidelines, and regulatory frameworks.

Act as the primary contact with global and local manufacture and distributors, regulatory authorities, notified bodies and SFDA.

Review product documentation, labeling, artwork, and marketing materials for regulatory accuracy.

Support cross-functional teams (Quality, Commercial, Supply Chain) to ensure regulatory alignment.

Maintain up-to-date knowledge of changes in regulations and assess impact on the business.

Mentor junior team members and support project execution.

Participate in audits, inspections, and internal compliance checks.

Qualifications & Requirements

Bachelor's degree in Pharmacy, Biomedical Engineering, Science, or related field.

Minimum 5 years of experience in Regulatory Affairs and registration of medical devices with the SFDA.

In-depth knowledge of regional and international regulatory frameworks.

Excellent communication, documentation, and problem-solving skills.

Ability to manage multiple projects and work in a fast-paced environment.

Ability to set meetings with the global manufactures and local distributors to discuss and explain MD registration process.

High attention to detail and strong ownership mindset.

Why Join Us?

Opportunity to lead critical regulatory operations and influence market access.

Work in a dynamic environment with strong growth opportunities.

Competitive salary, benefits, and career development pathways.

Collaborative team culture and supportive leadership.

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