Regulatory Affairs Specialist – Termporary Contract

Job Description

Contract: 4 months (project based)

Regulatory Affairs Specialist will provide regulatory support to achieve local product registrations and market authorizations in countries of Middle East and Africa, Turkey and Iran, with focus on GCC countries. He/she will ensure labelling/packaging compliance of all new and existing medical devices regarding country requirements and will apply for marketing material approval where required.

Job Responsibilities:

– Responsible for Marketing Authorization Application submission at health authorities in MEA countries, besides to variation and license renewal submissions. This includes requesting from Global Regulatory the registration documents, compiling, dispatching to distributors, and communicating with regulatory departments of local distributors & health authorities for final approval of license.
– Collaborating with EMEA labelling team on changes requested to over-labels & IFUs to ensure that they are in line with local legislations in markets as well as company requirements.
– Providing distributors with necessary documents and certificates to apply for import permits.
– Ensuring that the company’s regulatory and statutory requirements are met.
– Reviewing & signing off on advertising & promotional materials according to SoPs, to ensure all regulatory requirements are met including local language review.
– Responsible for applying, discussing, and following up with Heath Authorities to get the necessary approvals for marketing materials.
– Assessing MEA markets for changes communicated by Global Regulatory before the implementation to ensure compliance of shipments into MEA countries.