Job Description

JOB DESCRIPTION: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.Abbott Rapid Diagnostics (ARDx) is a sub-division of Abbott Diagnostics, created from the acquisition of Alere.ARDx believes that when diagnosing and monitoring health conditions, knowing now mattersxe2x84xa2. ARDx delivers on this vision by providing reliable and actionable information through rapid diagnostic tests, enhancing clinical and economic health outcomes globally. ARDx focuses on rapid diagnostics for infectious disease, cardio-metabolic disease and toxicology. For more information on ARDx, please visit www.alere.com.The OpportunityThe role RA specialist for obtaining in country regulatory approvals for Ardx products in the territory assigned, ensuring products distributed are in compliance with appropriate African Country regulations.WHAT WILL YOU DO?Product Registrations

• Responsible for the facilitation of all product registrations of Abbott products in Affiliate and Distributor countries in the defined territory.

• Works closely with commercial in aligning with required registrations or finding alternate pathways with authorities for products when under registration.

• Communicates and clarifies (where required) registration requirements communicated by distributors / commercial management to Legal Manufacturers

• Supports the Regulatory and Quality Director with the development of registration plans in accordance with business plans

• Provides visibility of ongoing product registrations and its status to the Regulatory and Quality Director and or other stakeholders.

• Follows up with regulatory authorities on registration submissions until registered.

• Coordinates and communicates with the Legal manufacturer and distributor for certification evaluations when required

• Assists in the a. communication of expected product design changes to distributors,

b. collects information from distributors on impact of planned design changes,c. follows up with Legal manufacturer and distributor on actions resulting from design changesRegulatory intelligence:xe2x96xaa Update the GRID (Abbott Regulatory Database) through regulatory intelligence gathered via Regional Directors, Industry committees and Distributorsxe2x96xaa Assist the Regulatory and Quality Director in communicating and informing Abbott legal manufacturers of relevant expected regulatory changes in the defined territoryxe2x96xaa Together with the QARA team, promotes awareness of regulatory and customer requirements throughout the organisation through organised training programmes as and when required.Support:xe2x96xaa Assist the Regulatory and Quality Director in supporting business operations for product registrations within the defined territory.xe2x96xaa Assist the Regulatory and Quality Director in product modification reporting and adverse event reporting to regulatory Authorities within the defined territory, as required

• Responsible for implementing and maintaining the effectiveness of the Abbott Quality System, when it applies to Regulatory compliance of procedures are upheld.

Qualifications:

• Degree in Health Sciences and an additional business-related qualification.
• A minimum of 3 Years of regulatory ideally in medical devices.
• Experience having manager other African countries outside of South Africa is advantageous

Competencies:

• Strong negotiation skills and the ability to interact with external and internal customers and partners.
• Superior attention to detail and accuracy.
• Ability to overcome cultural and language barriers to provide effective solutions.
• Experience in conducting and handling audits and inspections.

Why Join Us?

• Be part of a global leader in healthcare.
• Work in a collaborative and innovative environment.
• Opportunities for professional growth and development.
• Make a significant impact on the quality and safety of healthcare products.

The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: RegulatoryDIVISION: ID Infectious DiseaseLOCATION: South Africa
Johannesburg : Abbott PlaceADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Yes, 10 % of the TimeMEDICAL SURVEILLANCE: NoSIGNIFICANT WORK ACTIVITIES: Not Applicable

Abbott