Clinical Affairs Scientist

VOLT•Pacheco, CA

1d•Onsite

About The Position

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 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 to, Scientific 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.

Requirements

Bachelor's or Master's degree in biochemistry, molecular biology, immunology, oncology, pathology, histotechnology, life sciences, or a related scientific field, with relevant industrial, academic, or clinical laboratory experience.
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.
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.
Adheres to SOPs, quality standards, continual improvement principles, and applicable root cause analysis activities.

Nice To Haves

A Ph.D. and/or M.D. in a relevant field is preferred but not required.
Experience with IVD products, 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.
Working knowledge of EU IVDR performance evaluation, PMS, and PMPF concepts and documentation; understanding of ISO 13485, applicable quality system requirements, and GMP principles.

Responsibilities

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 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 to, Scientific 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.
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.