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Medica Group is a leading partner in aesthetic medicine solutions and technologies. We represent the most prominent global companies in the fields of aesthetic medical equipment, skin products, and digital dentistry across MENA and Southeast Asia. Our team is diverse and passionate about improving lives through innovative skin and body care solutions. We are committed to forward-thinking, creativity, and providing excellent service in the distribution, marketing, and sales of our product offerings.
Role Summary:
As a Regulatory Affairs Specialist, you will be responsible for ensuring the legality of Medica Group’s product portfolio by obtaining the required approvals from the relevant legal entities and health authorities.
Key Responsibilities:
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Lead the registration process for new products and renew existing product registrations.
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Organize and manage regulatory files in compliance with health authority requirements.
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Coordinate with suppliers to obtain necessary documents for product registration.
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Establish and maintain strong relationships with health authority representatives, including doctors and other stakeholders.
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Provide sales and medical representatives with copies of product registrations as needed.
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Facilitate procurement processes by assisting with shipment clearance.
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Maintain product quality control documentation and handle defect reporting.
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Manage product registration for sub-distributors and assist them with regulatory processes.
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Obtain import permits for medical machines and ensure compliance with relevant regulations.
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Collaborate with governmental authorities, such as the Dubai Municipality, Ministry of Health, and Federal Authority for Nuclear Regulation, to maintain import permits and legal licenses.
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Ensure regulatory compliance by monitoring local distributor activities and maintaining updated records of regulatory variations and renewals.
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Support internal stakeholders, such as sub-distributors and other external parties, with regulatory procedures.
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Prepare regulatory dossiers, submit product labeling changes, and manage applications for new product launches.
Qualifications & Skills:
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Bachelor’s Degree in Pharmacy.
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MOH and DHA License is mandatory.
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Proficiency in MS Office and online regulatory portals.
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Must be an Arabic speaker with excellent English communication skills (both written and verbal).
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Sound knowledge of relevant government sectors, procedures, and laws.
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Strong documentation and organizational skills.
Experience:
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A minimum of 2 years’ experience in a similar regulatory affairs role or as a pharmacist with the necessary licenses.
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Experience with regulatory processes in the medical, pharmaceutical, or aesthetic industry is a plus.
What We Offer:
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A dynamic, multicultural work environment.
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Opportunities for career growth and development within the company.
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Competitive salary and benefits package.
How to Apply:
If you are interested in this opportunity and meet the qualifications, please apply through the “Apply” button or get in touch with us for further details.
