Regulatory Affairs Support – Africa ( Contract ) at Abbott

The Role

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies.
In this role, the Regulatory Affairs Specialist (Fixed Term Contract) is responsible for Implements, and manages the required submissions / notifications for product registrations impacted by the changes in the various manufacturing sites and product names
As part of the Abbott integration and to ensure compliance of regulations for IVDs and medical Devices in the designated territory

Responsibilities
Assists the Director Regulatory and Quality:

• in supporting changes impacted to product registrations within the defined territory
• with the development and facilitation of variance submissions for affected sites/ products and prioritize in accordance with Abbott Africa business plans / Legal manufacturers implementation plan in the defined territory.
• in providing visibility and reporting of ongoing product change submissions and its status to other stakeholders with the use of the product registration trackers where required
• in the notification of expected product label / design changes received from Legal manufacturers onto distributors and authorities,
• collects such registration information from distributors and authorities on their impact and informs the Legal manufacturer and distributor on actions resulting from these changes
• and keeping abreast of such changes in the defined territory, and communicating and clarifying when required, the registration requirements pertaining to the changes
• in communicating and informing the Legal manufacturers of the updates to the registration requirements into GRID for Africa (Alere Regulatory Database)

Requirements

• Bachelor’s degree in science or equivalent
• Minimum 2 Years’ experience within the medical industry in Regulatory environment
• Experience in submissions of Product Registration Dossiers and other Registration documentation
• Competent in Word and Excel
• French Language and advantage
• Insight of the Regulatory Requirements of the region an advantage