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Regulatory Affairs Manager

3 weeks ago

Dubai, Dubai, United Arab Emirates Client of Michael Page Full time
Regulatory Affairs Manager - Middle East

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

Regulatory Affairs & Compliance

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

Post-Market Compliance & Vigilance

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

Cross-Functional Collaboration

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

The Successful Applicant

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

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