Clinical Affairs Scientist

VOLT • Pacheco, CA

1d • Onsite

About The Position

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.

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.
• 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.

Nice To Haves

• 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.

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 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 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.
• Other duties as assigned by Management.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level