Contract: 12 months (renewable and extendable)

Employment: Outsourced through ManpowerGroup Middle East

Role:

As a Regulatory Affairs Associate – Gulf, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

Job Responsibilities:

Manage all regulatory activities related to the Rebranding project in Gulf
Meet the Rebranding deadlines and timelines in Gulf
Manage all regulatory activities related to the spin off project in Gulf
Meet the spin off deadlines and timelines in Gulf
Work cross functionally with all stakeholders locally and with the design center teams to define all steps / activities / plans related to the rebranding and spin off projects
Ensure full Regulatory Compliance in doing health care business in Gulf.
Secure registrations, imports permission, and shipments clearance by a regulatory affairs
Support the business team to achieve yearly business objectives
Provide regulatory intelligence and obtain approvals for regulatory product submissions
Perform all the regulatory activities necessary for registering company health care products (medical devices and pharmaceuticals) as per the local regulations and maintain their licenses.
Support regulatory activities for business tender participation
Early regulatory assessment and involvement in the New Products Introduction process.
Perform all activities related to products quality (vigilance, pharmacovigilance, compliant handling, recalls)
Collaborate with the regulatory team in the headquarters to fulfil the local regulatory requirements
Monitor emerging changes affecting medical devices and pharmaceutical regulations in Gulf

Requirements and Qualifications:

Bachelor's degree or higher (completed and verified prior to start)
2 to 5 years experience in regulatory Affairs
Scientific university degree is required for this position
Regulatory Affairs expertise in Gulf is required
Excellent project management skills
Excellent communication skills and cross functional collaboration in English and Arabic
Excellent organizational skills

Regulatory Affairs Associate - Medical Devices and Pharma