Stellar Consulting Solutions, LLC · 6 hours ago
Staff Scientist
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Responsibilities
Contribute as local SME to the design, execution and interpretation of preclinical safety, biocompatibility, analytical chemistry, and toxicological evaluation strategies and programs according to relevant regulatory requirements; including review of literature and assessment of compliance. Collaborate with CPDT SMEs, project teams, business unit regulatory affairs staff, R&D staff and outside suppliers as required to help define product testing requirements and coordinate with the project team to provide CPDT deliverables.
Serve as Sponsor Representative for biocompatibility and chemistry studies and contribute to design, execution, and interpretation of preclinical, biocompatibility, chemistry and toxicological evaluation programs for medical devices.
Support EU MDR remediation efforts, create biocompatibility evaluation reports, and conduct testing as needed to ensure compliance under the EU MDR.
Maintain historical databases and perform searches of historical data, as needed.
Qualification
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Required
Bachelor’s degree in toxicology or a closely related field and a minimum of 8 years of pre-clinical medical device development experience OR Master’s degree in toxicology or a closely related field and a minimum of 5 years pre-clinical medical device development experience OR PhD Degree in toxicology or a closely related field and a minimum of 2 years pre-clinical medical device development experience years relevant experience or a combination of equivalent education and relevant experience.
Preferred
Board certification in toxicology preferred (e.g., DABT, ERT)
Experience in a GLP preclinical environment preferred.
Company
Stellar Consulting Solutions, LLC
Stellar Consulting Solutions, LLC, is a boutique business & technology consulting company headquartered in Atlanta, GA.
H1B Sponsorship
Stellar Consulting Solutions, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Growth StageCompany data provided by crunchbase