Regulatory Affairs Specialist (1-Year Fixed-Term Contract) at Abbott

What You’ll Do:

• Responsible for the implementation of regulatory compliance as required by international and local regulations and Abbott policies and procedures.
• Responsible for supporting and maintenance of regulatory approval of all Core Diagnostics products intended for distribution in English speaking regulated countries in Africa.
• Engages with the Distributor and liaise with local Regulatory Authorities as applicable and in alignment with regulatory strategy and RA Manager.
• Submit documentation for registration and re-registration for distributor countries.
• Support discussions with local authorities to better understand regulations, build relationship and clarify regulatory requirements.
• Assess product changes to ensure compliance with regulatory requirements.
• Monitor local regulations, e.g. language requirements and medical event reporting and support Regulatory Intelligence process.
• Support and execute strategies to comply with regulations in order to achieve early market entry and cost-effective business operation while maintaining regulatory compliance.
• Participates and represents Abbott CoreDx in trade association meetings and at conferences in alignment with local RA Manager and as applicable.
• Provide support for Adverse Event and Field Action reporting as necessary.
• Maintain internal and divisional regulatory databases (IRIS).
• Support RA and/or QA Manager during internal and external audits as necessary.
• Acts as back-up for local RA Manager for regulatory tasks in the region.

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Business Administration or equivalent.
• Technical skills related to IVD or Medical Devices
• Working knowledge of Quality Management Systems
• Fluent in English (written and spoken)
• 3-5 years of experience in the medical device / IVD industry preferably in Regulatory Affairs or Quality Assurance

Preferred Qualifications

• Knowledge of PC-based application.
• Experience to work in international environment/ projects. Cultural sensibility.