Rachael has spent the last decade in the life science industry and specialises in regulatory affairs, particularly in medical devices in the biomedical sector. She has extensive experience creating regulatory strategies for product development lifecycles.
Rachael is responsible for managing projects, the compilation of design history files, risk assessment, consulting with regulators and test houses on behalf of our clients, gap analysis, and supporting the design of product packaging, labelling and leaflets.
What is your approach to regulatory affairs?
First and foremost, understanding the product and understanding the target markets and goals, particularly timeline milestones. Every client has a unique business model, so it is important to recognise expectations. To navigate a pathway through the development process, it is vital to identify strengths on all sides, but also opportunities for gaining experience.
What interests you?
Gardening, DIY, getting outside and exploring nature.
Rachael joins the team in support of the continued expansion into medical and other regulated markets.