Job Description

Regulatory Affairs Specialist - sandton SummaryWe have an exciting opportunity in Johannesburg for a Regulatory Affairs Specialist. This will be a hybrid based role and you will be responsible to develop, maintain and execute the Southern Africa regulatory operational plans. We are the makers of possibleBD is one of the largest global medical technology companies in the world. Advancing the world of healthxe2x84xa2 is our Purpose, and itxe2x80x99s no small feat. It takes the imagination and passion of all of usxe2x80x94from design and engineering to the manufacturing and marketing of our billions of MedTech products per yearxe2x80x94to look at the impossible and find transformative solutions that turn dreams into possibilities. Why join us?A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, youxe2x80x99ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place. Become a maker of possible with us! Our vision at BDThe Regulatory Affairs team is helping to ensure speed to market for BDxe2x80x99s innovative medical technologies by having an acutely patient-centric mindset.About the roleYou will work closely under the direction of the Head of Regulatory Affairs Africa, you will have primary responsibility for regulatory service and support in Southern Africa which these activities include - the preparation of registration files, coordination of registration planning and tracking, tender support and local country sales organizations support. Main responsibilities will includeCoordinating and preparing the registration plans, submissions, tracking, monitoring, and recording 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 in the territory.Addressing related inquiries initiated by the sales organizations, product managers or RA colleagues.Conducting regulatory intelligence and impact assessments for various countries.Assisting with the execution of Regulatory Quality Management System responsibilities, including reporting to the Health Authority as required.May perform other duties as required. About youBachelorxe2x80x99s degree, preferably in a scientific, biomedical, health sciences, or engineering field.Previous regulatory experience in the medical device and/or in vitro diagnostic device and/or pharmaceutical area.Experience in the process of preparing and filing registration submissions and preparing regulatory documentation.Team oriented, with effective communication and interpersonal skills.Strong problem-solving skills and attention to detailAbility to manage and prioritize multiple deliverables under tight deadlines.Ability to work in a matrix organization.Excellent communication skills in English, both verbal and written.Advanced computer skills (MS Office Suite) and other IT applications/programs Click on apply if this sounds like you!Primary Work LocationZAF Sandton

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