Regulatory Affairs Specialist

7 months ago

Sandton, South Africa BD Philippines Full time

**Be part of something bigger at BD.** Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health. At BD, you can make a true difference of one.

**Job Type**:
Full-Time**Job Level**:
Entry to Senior**Travel**:
Varies**Salary**:
Competitive**RESPONSIBILITIES**:
**Job Description Summary**: We 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 possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to 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, you’ll 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 BD

The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset.

About the role

You 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 include
- Coordinating 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 you
- Bachelor’s 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 detail
- Ability 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.

**Primary Work Location**: ZAF Sandton

**Additional Locations**:
**Work Shift**:

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