Biocompatibility Cum Toxicologist

Menlo Park, CA 94025

Job Category: Healthcare-Other Job Number: 156237

Job Description

Job Title:               Biocompatibility Cum Toxicologist

Location:               Menlo Park, California, US - 94025

Job Type:               Contract

Duration:               6+ Months

About Our Client: Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives

Job Description:

  • Biocompatibility cum Toxicologist will work with a diverse team of subject matter experts charged with the responsibly to develop, execute and represent state of the art multidisciplinary Medical Device safety evaluation strategies. He/she will bridge any and all internal or external organizational boundaries to ensure seamless safety coverage for the patients, doctors and other users of our medical devices. The candidate must possess the communication and people skills to represent the department within the organization and externally at scientific meetings, regulatory presentations and international standards organizations
  • Working with project teams, prepare biological evaluation strategies, execute testing and risk assessment activities as needed
  • Partner with Regulatory Affairs, Supplier Management, Life Cycle Materials& Project Teams for regulatory submissions supporting pre-clinical safety
  • Serve as Sponsor Representative and Study Monitor for biocompatibility studies placed at contract laboratories
  • Summarize, analyze, and interpret raw data from test reports.
  • Effectively communicate with laboratories in oral & written form regarding test requirements, issues, deviations & special requests
  • Participate in test study design as necessary
  • Review & approve or modify protocols & study proposals for contract labs
  • Perform literature searches as appropriate for material submissions
  • Communicate with internal and external experts to assist in resolution of biocompatibility challenges
  • Support NPD Development and Design Change Teams in material selection
  • Pre-clinical support for medical products using in vitro & in vivo models
  • Assist in maintenance of corporate biocompatibility database
  • Apply biocompatibility standards to the evaluation of Ethicon devices
  • Ensure that testing meets all international & domestic test requirements according to ISO (International Standards Organization), FDA (Food & Drug Administration)-CDRH (Center for Devices & Radiological Health), ICH (International Conference on Harmonization) & GLP (Good Laboratory Practice) guidelines
  • Collaborate with associates of diverse technical backgrounds (chemistry,  materials science, engineering, regulatory, etc., ) to achieve desired project outcomes; interact closely & providing consultative direction to R&D, Clinical Affairs, Regulatory Affairs & Supplier Management, reviewing regulatory submissions and providing input.

About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities

Reach Out To A Recruiter

Recruiter:             Jeff Kasula

Email:                   jeffk@askstaffing.com

Phone:                  678-890-5105

Meet Your Recruiter

Jeff Kasula
Sr. Resource Specialist

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