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A scientific development firm based in Pretoria seeks a qualified professional to support product development and regulatory activities. The ideal candidate has strong analytical skills, experience in scientific writing, and a relevant degree. Key responsibilities include managing product dossiers and improving manufacturing processes. This role requires effective communication and problem-solving abilities in a fast-paced environment.
Responsibilities include supporting end-to-end product development (formulation, design controls, validation, documentation, and transfer to production) as well as maintaining existing products to ensure quality, stability, safety, and regulatory compliance in a GMP/ISO environment.
The role involves both collaboration with internal teams and independently managing workstreams. Independent research and product development: Plan, design, execute, and troubleshoot experiments; Conduct literature reviews and self-directed research to support product development; Lead the development, optimisation, and validation of formulations, test methods, and processes; Manage multiple tasks and long-term development projects simultaneously.
Technical problem-solving and process support: Solve complex technical challenges affecting formulations or manufacturing; Support and improve production processes and resolve raw material or process-related issues; Perform material acceptance, supplier evaluations, and introduce new materials / equipment as needed; Perform data trending, technical assessments, and stability evaluations; Quality, compliance and documentation: Maintain accurate, complete technical documentation in line with QMS requirements; Participate in product risk management activities, including hazard identification, assessment, and mitigation; Ensure controlled documents (procedures, forms, lists) remain accurate and updated; Support nonconformity investigations and CAPA activities.
Regulatory responsibilities: Compile complete dossiers for new products (Technical Files, Design Files, Clinical Evaluation inputs, Biocompatibility inputs) per international standards; Ensure existing product dossiers remain updated and aligned with regulatory requirements; Support CE marking, SAHPRA submissions, and international regulatory activities; Ensure labelling, IFUs, and end-user information are compliant and current; Support PMS/PMCF activities.
Cross-functional and external support: Provide technical input to Quality, Production, and Procurement teams; Assist with technical and scientific client queries; Train and support staff on testing equipment and technical processes.