Job Description

Regulatory Affairs Specialist
Essity is a leading global hygiene and health company which develops, produces and sells Health & Medical, Consumer Tissue and Professional Hygiene products and solutions and has a strong global presence.
We are looking for a suitably qualified & experienced Regulatory Affairs Specialist to join our Quality Assurance/Regulatory Affairs team based in Pinetown on a 6 months fixed-term contract and will report to the QA/RA Manager.
About the Role
The successful incumbent will need to ensure that the products in his/her assigned assortment within their regulated area (Medical Devices; Cosmetics/Biocides; all others) are documented and processed in accordance with internal regulatory and quality processes and procedures for the purpose of obtaining and maintaining market authorization locally and internationally.
What You Will Do
Compile documentation and technical product files necessary for the market authorization and/or registration of the products assigned.
Prepare regulatory documentation required for the manufacture, distribution and marketing of products in line with various product regulations.
Coordinate and collect relevant data and documentation for the submission of tenders both locally and internationally.
Establish and maintain a regulatory authorization overview for registration.
Give input to support processes as reflected in GMS (Global Management System) on regulatory requirements.
Maintain a Standard Library of all required standards, updates standards as needed and informs relevant stakeholders thereof.
Who You Are
Must have Matric and a Bachelor's Degree or equivalent in Quality and Regulatory Affairs or relevant scientific tertiary qualification.
Minimum of 3-5 years experience in a similar position within a medical device/pharmaceutical/ manufacturing environment.
Must have proficient skills on MS Office and SAP system.
Must have excellent communication skills (verbal and written).
Report writing ability with good administrative skills.
Must have high level of analytical reasoning, problem solving and decision-making ability.
Be able to collaborate and work across functional teams.
What We Can Offer You
Our purpose, Breaking Barriers to Well-Being, provides meaning to everything we do. Join us to improve well-being for people and drive positive change for society and the environment. At Essity, you'll feel valued, empowered to grow, and challenged to achieve business results in a collaborative and open atmosphere. Innovate for Good | Excel Together | Be You with Us
Location
Pinetown, South Africa
Application End Date:
25 Jun 2025
Job Requisition ID: Essity254567