Regulatory Affairs Specialist - Johannesburg - Abbott Laboratories

    Abbott Laboratories
    Abbott Laboratories Johannesburg

    6 days ago

    Default job background
    Healthcare
    Description

    Regulatory Affairs Specialist

    Job Overview

    Abbott is a global leader in healthcare, and we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be based in South Africa and will focus on obtaining regulatory approvals for Abbott products in the assigned territory.

    About Us

    At Abbott, we believe that diverse ideas, perspectives, and expertise allow us to create life-changing solutions that help people live healthier lives. Our company offers numerous opportunities to explore your interests and achieve your career and personal goals.

    The Role

    This is an exciting opportunity to work with a dynamic team and contribute to the development of registration plans in accordance with business plans. The successful candidate will be responsible for facilitating product registrations of Abbott products in Affiliate and Distributor countries in the defined territory.

    Responsibilities

    • 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.
    • Regulatory Intelligence:
      • Update the GRID (Abbott Regulatory Database) through regulatory intelligence gathered via Regional Directors, Industry committees and Distributors.
      • Assist the Regulatory and Quality Director in communicating and informing Abbott legal manufacturers of relevant expected regulatory changes in the defined territory.
    • Support:
      • Assist the Regulatory and Quality Director in supporting business operations for product registrations within the defined territory.
      • Responsible for implementing and maintaining the effectiveness of the Abbott Quality System, when it applies to Regulatory compliance of procedures are upheld.

    Requirements

    • 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.

    What We Offer

    • 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.
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