Mentis Systems · 19 hours ago
Staff Scientist II
United States
Contract
Remote
Mid, Senior Level, Lead/Staff
5+ years exp
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Hiring Manager
R setty
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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, BD 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 within BD.
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.
Working knowledge of computers (Word, Excel, Access, PowerPoint, SharePoint).
A broad background in biology/biocompatibility, toxicology and analytical chemistry including familiarity with recent methodologies and evaluation techniques (i.e., ISO 10993 and related guidance).
Ability to communicate and work effectively with national and international, internal, and external teams.
Must be able to multitask and operate effectively within a diverse work environment.
Must be team oriented and have strong interpersonal skills and customer focus while functioning independently as an SME.
Must have excellent scientific written and verbal communication skills.
Preferred
Board certification in toxicology preferred (e.g., DABT, ERT)
Experience in a GLP preclinical environment preferred.
Experience in a United States or EU medical device setting is preferred.
Company
Mentis Systems
Mentis Systems specializes in CRM and ERP Integration, application and infrastructure outsourcing and other IT services.
1001-5000 employees
H1B Sponsorship
Mentis Systems 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
2022 (1)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Shabu Khan
President & Chief Operating Officer
Company data provided by crunchbase
