Job Description
We are seeking a highly skilled and experienced Scientific Development Leader to join our team.
* Develop and maintain an inventory of Notified Body requirements and responses for animal testing, working closely with Regulatory personnel.
* Collaborate with our advanced science and modelling group to coordinate bench testing, utilise lab models and technologies, and provide input for improvement.
* Design complex experiments, including deep dives on technical feasibility or test-to-failure experiments. Responsible for protocol development, report writing, and presentations to address research or regulatory questions.
* Participate in new product development as a core team member, representing physician needs and practical use. Practical problem solving required.
* Identify and manage key preclinical risks throughout the product lifecycle.
Responsibilities
* Manage and document all relevant information to ensure compliance with quality standards.
* Collaborate with R&D, Quality, and Regulatory departments to ensure seamless execution of experiments and bench studies.
* Develop Target Product Profiles (TPPs), aligning them with areas of greatest need based on physician input and preclinical testing experience.
Requirements
* Honours degree in Biomedical Engineering, Biological Sciences, or related medical / scientific field.
* A minimum of 6-10 years' experience in experimental design within the medical device industry.
* Prior experience developing animal study protocols.
* Strong design and technical ability based on a broad and deep knowledge of fundamental scientific principles.
* Excellent writing, presentation, and verbal communication skills essential.