Clinical Affairs Scientist

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Volt is immediately hiring forClinical Affairs Scientistin Pacheco CA

As a Clinical Affairs Scientistyou will:

Job Description:

The Scientist I Clinical Affairs is a member of the Clinical Affairs function within Research and Development and works with minimal supervision to provide scientific and clinical support throughout the IVD product lifecycle. The position has primary responsibility for scientific literature evaluation EU IVDR performance evaluation and post-market documentation including Scientific Validity State of the Art Analytical Performance Clinical Performance Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF) activities. The role also supports R&D and Quality Control through laboratory testing and slide grading interprets scientific and performance data and prepares or reviews technical documentation requiring scientific expertise. The Scientist I collaborates cross-functionally with R&D QA/RA QC and other internal and external scientific partners.

Day to Day Responsibilities:

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Performs IHC in situ hybridization (ISH) fluorescence in situ hybridization (FISH) procedures and routine laboratory functions in support of Clinical Affairs and R&D activities.
• Supports R&D projects and testing activities by preparing and performing studies documenting results interpreting experimental data and contributing scientific conclusions to design and technical documentation.
• Performs and documents for slide grading for R&D and Quality Control (QC) including evaluation of staining quality specificity sensitivity background morphology and other applicable performance or acceptance criteria.
• Conducts systematic scientific and clinical literature searches and reviews; develops and maintains search strategies and evaluates publications for relevance quality and applicability to IVD products.
• Prepares reviews and maintains EU IVDR performance evaluation documentation including but not limited toScientific Validity (SV) State of the Art (SOTA) Analytical Performance (AP) Clinical Performance (CP) Performance Evaluation Plans (PEP) and Performance Evaluation Reports (PER) as applicable.
• Prepares reviews and maintains EU IVDR Post-Market Surveillance (PMS) documentation including PMS Plans PMS Reports and/or Periodic Safety Update Reports (PSUR) as applicable and supports periodic evaluation and trending of post-market data.
• Prepares reviews and maintains Post-Market Performance Follow-up (PMPF) documentation including PMPF Plans and PMPF Evaluation Reports and supports execution tracking and follow-up of PMPF activities.
• Reviews and scientifically evaluates relevant post-market information including complaints customer feedback vigilance or safety information published literature external quality assessment data and other product performance information in collaboration with QA/RA and other functions.
• Supports risk management and benefit-risk evaluation by providing scientific clinical performance and post-market evidence and conclusions relevant to assigned products.
• Writes reviews and edits technical documentation for IVD products including protocols reports datasheets scientific summaries and other controlled documents requiring scientific expertise.
• Coordinates participation in NordiQC module testing performs applicable NordiQC protocols and supports evaluation and documentation of results.
• Collaborates with internal cross-functional teams universities external laboratories alpha and beta sites and other clinical or scientific partners. Some travel may be necessary.
• Maintains awareness of scientific clinical regulatory and state-of-the-art developments relevant to assigned products; attends applicable seminars webinars and workshops and may support abstracts and publications.
• Reviews test forms and other user-editable or controlled forms of R&D staff members as assigned to support scientific accuracy completeness and consistency prior to submission or approval.
• Other duties as assigned by Management.

This is a full-timeopportunity.

The ideal candidate will have:

• Bachelors or Masters degree in biochemistry molecular biology immunology oncology pathology histotechnology life sciences or a related scientific field with relevant industrial academic or clinical laboratory experience. A Ph.D. and/or M.D. in a relevant field is preferred but not required.
• Experience with IVD products IHC scientific or clinical literature evaluation EU IVDR performance evaluation PMS/PMPF and scientific or medical writing is preferred.
• Certification as a Histotechnologist or other relevant certification by the ASCP is a plus.
• Strong scientific and technical writing skills with the ability to prepare clear well-supported and understandable documentation.
• Ability to critically evaluate scientific literature clinical evidence analytical and clinical performance data and post-market information.
• Working knowledge of EU IVDR performance evaluation PMS and PMPF concepts and documentation; understanding of ISO 13485 applicable quality system requirements and GMP principles.
• Strong knowledge of IHC and staining interpretation with the ability to consistently grade slides and communicate scientifically sound conclusions.
• Ability to analyze experimental and post-market data identify trends or gaps and translate findings into appropriate scientific documentation and follow-up activities.
• Exceptional proofreading accuracy attention to detail and commitment to data integrity and document quality.
• Adheres to SOPs quality standards continual improvement principles and applicable root cause analysis activities

Pay rate: $85 - $90/hr on W2

Benefits: Volt offers benefits (based on eligibility) that include the following: health dental vision term life short term disability AD&D 401(k) Sick time and other types of paid leaves (as required by law) Employee Assistance Program (EAP).

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.

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 or call (866). 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. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance the Los Angeles Fair Chance Initiative for Hiring Ordinance and other applicable laws.

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