Clinical Affairs Scientist I

Volt - Clinical Affairs Scientist I

Build your future with Volt!

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.

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 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.

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 hour

Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

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).

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 contact the appropriate channel.

Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with applicable laws.

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