Regulatory Affairs Specialist

The 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?

• 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 communication of expected product design changes to distributors, collects information from distributors on impact of planned design changes, and follows up with Legal manufacturer and distributor on actions resulting from design changes.
• Updates the GRID (Abbott Regulatory Database) through regulatory intelligence gathered via Regional Directors, Industry committees, and Distributors.
• Assists the Regulatory and Quality Director in communicating and informing Abbott legal manufacturers of relevant expected regulatory changes in the defined territory.
• Together with the QARA team, promotes awareness of regulatory and customer requirements throughout the organisation through organised training programmes as and when required.
• Assists the Regulatory and Quality Director in supporting business operations for product registrations within the defined territory.
• Assists 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 managed other African countries outside of South Africa is advantageous.
• 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.