Clinical Affairs Scientist
About The Position
Volt is immediately hiring Clinical Affairs Scientist I in Pacheco California. As a Clinical Affairs Scientist I, you will: Perform and support 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, vigilance/safety 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, QA/RA, QC, external laboratories, universities, and clinical/scientific partners. Maintain awareness of relevant scientific, clinical, regulatory, and state-of-the-art developments. Work independently while managing multiple priorities and meeting established deadlines.
Requirements
- Strong scientific and technical writing experience.
- Hands-on or substantial experience with pathology slide grading/review and tissue interpretation.
- Experience interpreting tissue morphology and staining, particularly IHC and/or related tissue-based assays.
- Strong microscopy skills and comfort reviewing pathology slides.
- Experience with regulatory requirements, particularly ICH guidelines and/or medical-device regulatory environments.
- Strong attention to detail, documentation, proofreading, and data integrity.
- Ability to critically evaluate scientific literature and scientific/clinical data.
- Ability to work independently with minimal supervision.
- Strong learning agility and ability to become proficient in new procedures, systems, and regulatory requirements.
Nice To Haves
- Ph.D. or M.D. in a biological or medical science field.
- ASCP Histotechnologist (HTL) certification or similar credential.
Responsibilities
- Perform and support 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, vigilance/safety 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, QA/RA, QC, external laboratories, universities, and clinical/scientific partners.
- Maintain awareness of relevant scientific, clinical, regulatory, and state-of-the-art developments.
- Work independently while managing multiple priorities and meeting established deadlines.
Benefits
- health
- dental
- vision
- term life
- short term disability
- AD&D
- 401(k)
- Sick time
- other types of paid leaves (as required by law)
- Employee Assistance Program (EAP)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
