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Medasource · 1 day ago

Senior Preclinical Research Scientist

Santa Clara, CA

Full-time

Onsite

Senior Level

5+ years exp

Medasource is focused on using digital technology to enhance surgical efficiency and improve patient outcomes. The Senior Preclinical Research Scientist will lead and support product evaluations, conduct preclinical studies, and ensure compliance with regulatory standards in the development of medical devices.

Health CareMedical

Growth Opportunities

Hiring Manager

Jenna Kimack

Responsibilities

Leads and supports product evaluations involving animate, inanimate, and cadaveric models

Performs research supporting development of products or procedures in minimally invasive robotic surgery

Assisting or conducting investigations for medical device development and preclinical evidence generation aligned to R&D, Regulatory, and Commercial needs

Coordinate and ensure accurate documentation of laboratory activities

Conduct lab activities in compliance with USDA, AAALAC, and J&J Animal use policies

Ensure compliance with 21 CFR Part 58 – Good Laboratory Practices

Contribute and support the design of appropriate studies to meet premarket and post market needs

Design, plan and execute preclinical animal studies for the assessment of safety, performance, and effectiveness

Act as study coordinator in support of the Study Director

Act as Study Director projects of varying levels of complexity

Assess, communicate, and manage the risks associated to the preclinical evaluation of products

Assist in appropriate interpretation and dissemination of all evidence generated, based on evidence dissemination strategy, including study reports, abstracts, manuscripts, etc

Demonstrate the ability to work effectively in a team-oriented environment that embraces ownership and accountability for innovation, change, risk, and flexibility

Build successful relationships internally and develop partnerships with key business partners

Qualification

Preclinical research experienceMedical device developmentGLP environment experienceAnimal welfare regulationsLarge animal modelsRegulatory submissionsTeam collaborationDocumentation practices

Required

A minimum of a bachelor's degree in Biological Science or a related discipline is required

A minimum of 5 years of related scientific / technical experience within preclinical research is required

Experience in preclinical science and processes along with an understanding of medical device development processes, related healthcare market environment, clinical trends, and preclinical regulations is required

Track record of contributing to preclinical programs on time, within budget and in compliance to SOPs and regulations is required

Experience working in a GLP environment and direct experience executing preclinical studies

Understanding of good documentation practices

Familiarity with animal welfare regulations and IACUC

Preferred

Experience working in Medical Devices or Robotics is preferred

Experience working with large animal models is desired

Experience in support of global regulatory submissions for medical devices, biologics, or drugs (including PMA/BLA/NDA and/or their global counterparts) is preferred