Chief Research Expert

1 day ago

Galway, Galway, Ireland beBeeScientist Full time
Job Description:

As a Principal Scientist, you will play a crucial role in evaluating new and current labs, serving as the primary point of contact for logistics and communication. You will collaborate with Regulatory to develop and maintain an inventory of Notified Body requirements and responses over the years for animal testing.

In this position, you will create a 'test-to-fail' strategy to conduct bench testing on products in development, characterizing their limits from a usability perspective. You will work closely with in-house physicians and engineers to perform the testing.

You will effectively work with our in-house advanced science and modelling group to coordinate and utilize the lab, models, and technologies for related bench testing. You will also provide input for improvement.

Key responsibilities include developing and implementing highly complex experiments, including deep dives on technical feasibility or test-to-failure experiments. You will be responsible for protocol development, report writing, and presentations to address research or regulatory questions, collaborating with R&D, Quality, and Regulatory for all experiments and relevant bench studies.

You will utilize exposure to clinicians to identify areas of unmet need and use this information to innovate new solutions. Participation in new product development as a core team member, representing physician needs and practical use, is also essential.

Additionally, you will participate in Target Product Profile (TPP) generation, bringing physician needs and preclinical testing experience to drive aligned TPPs with areas of greatest need. You will identify and manage key preclinical risks throughout the product lifecycle.

Finally, you will ensure documentation to appropriate standards and be responsible for managing documents through the Quality System.

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