Regulatory Assurance Specialist Job at Abbott Laboratories – in Johannesburg, Gauteng
Division: Abbott Diagnostics
DO WORK THAT MATTERS.
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.
In this role, the RA specialist is responsible for supporting regulatory compliance and registration for Abbott’s activities for diagnostics in English speaking countries in Africa.
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 regulated countries of English- speaking countries in Africa.
Submit documentation for registration and re-registration with distributor countries in support of transition of products and product registrations due to changes related to IVDR compliance requirements.
Assess product changes, to ensure compliance with regulatory requirements.
Monitor local regulations, e.g. language requirements and medical event reporting.
Support and execute strategies to comply with regulations in order to achieve early market entry and cost-effective operation of the business while maintaining regulatory compliance.
Provide support for Adverse Event and Field Action reporting as necessary.
Maintain internal and divisional regulatory databases (IRIS)
Provide support during audits as necessary.
Attend at least one RA-related developmental course (Abbott or Non-Abbott) as part of overall development plan
QUALIFICATIONS AND EXPERTISE
Minimum of 1 year experience within a Regulatory Affairs role.
Having worked within IVD or Medical Devices is prefered
Experience within Africa is advantageous.
Must be fluent in English.
Must have intermediate skills in Microsoft Word, Excel and powerpoint.
Tertiary qualification in Human sciences, Biochemistry, Pharmacy etc
Company: Abbott Laboratories –
Company Location: Johannesburg, Gauteng