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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 13485 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
REQUIREMENTS:
- Tertiary degree in Science or Engineering
- Master’s degree (MSc/MEng) strongly preferred
- Postgraduate specialisation in Chemistry/Chemical Engineering advantageous
- Experience in scientific technical/academic writing
- Experience in medical device or pharmaceutical development, manufacturing, or regulatory environments is advantageous, but not required.
Independence
- Able to work with minimal supervision after onboarding
- Takes ownership of tasks and solves problems independently
- Proactively identifies knowledge gaps and self-learns to close them
Problem-solving and critical thinking
- Strong analytical and troubleshooting ability
- Can break down complex or ambiguous problems into clear action steps
- Able to propose solutions and alternatives without being prompted
Multi-tasking and organisation
- Able to manage several projects at the same time
- Comfortable shifting between priorities as needed
- Strong organisational and time-management skills
Learning attitude and curiosity
- Eager to learn new systems, regulations, technologies, and scientific concepts
- Comfortable reading, researching, and understanding background material independently
Behaviour and work ethic
- Proactive, self-motivated, and accountable
- Resilient under pressure and able to make progress despite uncertainty
- High attention to detail, integrity, and professionalism
Communication
- Strong written communication skills, especially for technical/scientific writing
- Able to communicate effectively across departments
- Fluent in English (written and verbal)
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