Regulatory & Quality Manager
Jeanette has more than 25 years of industry experience in regulatory affairs and quality management systems. Prior to setting up her own consulting company, Jeanette held senior management positions within other regulatory and clinical consulting firms, as well as various positions within a global healthcare company. Jeanette has a Graduate Diploma in Biotechnology and a Masters in Medical Science (Drug Development).
Jeanette provides valued and insightful advice and strategic support for projects involving medical devices and medicines (prescription, biological, OTC and listed pharmaceuticals) in a range of therapeutic areas. Jeanette has managed a large number of registration and maintenance applications for medical devices and medicines, within various global markets, focussing on the AP region. Jeanette has developed effective working relationships with various regulatory agency evaluators and has been involved in pre-submission consultations with the TGA on a variety of topics. Additionally, as a Quality Auditor, Jeanette has experience in the development, implementation and assessment of quality management systems.