Regulatory Affairs Manager - Middle East

Our client is a global multinational looking to recruit a Regulatory Affairs Manager for their operations in Dubai. The person will be responsible for the Middle East region.

Job Description

This role is responsible for ensuring product compliance with regional health authorities, overseeing submissions, approvals, and post-market surveillance.

Regulatory Affairs & Compliance

1. Develop and implement regulatory strategies to support product registration and market access across the Middle East.
2. Prepare, submit, and manage regulatory dossiers for new registrations, renewals, and variations.
3. Act as the primary liaison with health authorities (MOH, SFDA, DHA, GCC DR, etc.) to ensure timely approvals.
4. Ensure labelling, packaging, and promotional materials comply with local regulatory requirements.
5. Monitor regulatory changes and provide strategic guidance on their impact on product compliance.

Post-Market Compliance & Vigilance

1. Ensure adherence to post-market surveillance and reporting obligations.
2. Manage adverse event reporting and product recalls in coordination with regional regulatory bodies.
3. Maintain up-to-date regulatory documentation and ensure inspection readiness.

Cross-Functional Collaboration

1. Work closely with R&D, Quality, Commercial, and Supply Chain teams to align regulatory strategies with business goals.
2. Provide regulatory input for product development, clinical evaluation, and market expansion plans.
3. Conduct internal training sessions on regulatory requirements for relevant teams.

Job Offer

The role offers a competitive salary and benefits.

Minimum Requirements

The ideal candidate for the role will:

1. Bachelor's or Master's degree in Pharmacy, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
2. 5+ years in regulatory affairs within medical technology, medical devices, or health care products.
3. Strong communication skills for regulatory interactions.
4. Ability to manage multiple country submissions and post-market compliance.