Clinical Affairs Scientist

Build your future with VoltVolt is immediately hiring Clinical Affairs Scientist I in Pacheco California.As a Clinical Affairs Scientist I you will Perform andsupport IHC ISH and FISH testing and related laboratory activities supporting Clinical Affairs and R&D. Conduct pathology slide review and grading evaluating staining quality specificity sensitivity background tissue morphology and predefined acceptance criteria. Interpret IHC ISH FISH and other tissue staining results using appropriate microscopy techniques. Review pathology slides and document grading results accurately and consistently. Complete associated scientific and technical documentation for slide grading and testing activities. Perform scientific and clinical literature searches and evaluations and assess publications for relevance to IVD products. Prepare review and maintain scientific and regulatory documentation supporting EU IVDR requirements including Scientific Validity SV State of the Art SOTA Analytical Performance AP Clinical Performance CP Performance Evaluation Plans PEP Performance Evaluation Reports PER Support Post-Market Surveillance PMS activities including PMS Plans PMS Reports and PSURs. Support Post-Market Performance Follow-up PMPF plans evaluations tracking and documentation. Evaluate complaints customer feedback vigilancesafety information published literature and other post-market data. Support risk management and benefit-risk assessments using scientific and clinical evidence. Prepare review and edit technical reports protocols scientific summaries datasheets and other regulated documentation. Support NordiQC module testing and evaluation of results. Analyze experimental and post-market data identify trends or gaps and document scientific conclusions. Work closely with R&D Clinical Affairs QARA QC external laboratories universities and clinicalscientific partners. Maintain awareness of relevant scientific clinical regulatory and state-of-the-art developments. Work independently while managing multiple priorities and meeting established deadlines.This is a full-time contract opportunity.The ideal candidate will have Strong scientific and technical writing experience. Hands-on or substantial experience with pathology slide gradingreview and tissue interpretation. Experience interpreting tissue morphology and staining particularly IHC andor related tissue-based assays. Strong microscopy skills and comfort reviewing pathology slides. Experience with regulatory requirements particularly ICH guidelines andor medical-device regulatory environments. Strong attention to detail documentation proofreading and data integrity. Ability to critically evaluate scientific literature and scientificclinical data. Ability to work independently with minimal supervision. Strong learning agility and ability to become proficient in new procedures systems and regulatory requirements.Preferred Qualifications Ph.D. or M.D. in a biological or medical science field. ASCP Histotechnologist HTL certification or similar credential.Pay Rate 87.00 - 90.87 per hourPay range offered to a successful candidate will be based on several factors including the candidates education work experience work location specific job duties certifications etc.Qualified candidates should APPLY NOW for immediate consideration Please hit APPLY to provide the required information and we will be back in touch as soon as possible.Benefits Volt offers benefits based on eligibility that include the following health dental vision term life short term disability AD&D 401k Sick time and other types of paid leaves as required by law Employee Assistance Program EAP.Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race color religion or belief national origin citizenship social or ethnic origin sex age physical or mental disability veteran status marital status domestic partner status sexual orientation or any other status protected by the statutes rules and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment please email hr_deptvolt.com or call 866 -898-0005. Please indicate the specifics of the assistance needed.Volt does not discriminate against applicants based on citizenship status immigration status or national origin in accordance with 8 U.S.C. § 1324b. 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