BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Johannesburg, South Africa
Job Description Summary
As a Regulatory Affairs Specialist, your main responsibility is to develop, maintain and execute the South African regulatory plan. Under the direction of the Manager Regulatory Affairs Africa, you will have primary responsibility for regulatory support in South Africa. These activities include: the preparation of registration files, coordination of registration planning and tracking, tender support and local country sales organizations support. Other key inputs include:
Coordinating the registration plan across the business segments
Working closely with the business regulatory affairs counterparts to capture the existing and upcoming regulatory expectations and take appropriate actions.
Maintaining a list of current registrations
Addressing related inquiries initiated by the sales organizations, product managers or RA colleagues
Assisting with the execution of Quality Management System responsibilities including complaint handling, product recalls, adverse event reporting
Educated with a bachelor’s degree, preferably in a scientific discipline, health sciences, or engineering - you will have a minimum of 3 years of regulatory experience in the medical device and/or in vitro diagnostic device and/or pharmaceutical area and will also have working knowledge of medical device and/or in vitro diagnostic device and/or pharmaceutical regulations. In addition to excellent all-round communicator and with strong prioritizing skills, you’ll also bring:
Experience in the process of preparing and filing registration submissions and preparing regulatory documentation.
Successful history of handling multiple projects, and prioritizing / scheduling activities and managing deadlines.
Fluency in English
If you’re passionate about healthcare and we’ve just described your career aspirations, then please click on the APPLY button.
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Primary Work Location
ZAF Johannesburg - Woodlands Dr
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.