Clinical Affairs Scientist

Volt; Martinez (CA); On-site; USD 243,560,000 - 260,380,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k)

Paid time off

Employee Assistance Program (EAP)

Job summary

Volt is seeking a Clinical Affairs Scientist in Pacheco, California. You will support R&D and QA for IVD products, performing IHC, ISH and FISH, reviewing literature, and maintaining EU IVDR documentation. Some travel may be necessary.

The ideal candidate holds a life sciences degree and has strong scientific writing, plus experience with PMS/PMPF and post-market data evaluation. This is a full-time contract with competitive pay and benefits.

Qualifications

• Bachelor’s or Master’s degree in life sciences; PhD/MD preferred but not required.
• Experience with IVD products, IHC, literature evaluation, EU IVDR, PMS/PMPF, and scientific writing preferred.
• ASCP certification is a plus.
• Strong scientific and technical writing skills for clear documentation.
• Ability to critically evaluate literature, clinical evidence and post-market data.
• Knowledge of EU IVDR, PMS, PMPF concepts and documentation.
• Knowledge of IHC and staining interpretation; ability to grade slides.
• Adheres to SOPs and quality systems; supports root cause analysis.

Responsibilities

• Performs IHC, ISH, FISH and routine lab functions to support Clinical Affairs and R&D.
• Supports R&D projects by preparing studies, documenting results, interpreting data.
• Performs slide grading for R&D and QC; evaluates staining quality and criteria.
• Conducts literature searches and evaluates relevance to IVD products.
• Prepares EU IVDR performance evaluation documentation (SV, SOTA, AP, CP, PEP, PER).
• Prepares EU IVDR PMS documentation and PMS data reviews.
• Prepares PMPF documentation and supports PMPF activities.
• Reviews post-market information with QA/RA and other functions.
• Supports risk management and post-market evidence conclusions.
• Writes and edits technical documentation for IVD products.
• Coordinates NordiQC testing and documents results.
• Collaborates with cross-functional teams; travel may be necessary.
• Keeps updated on developments; attends seminars/workshops; supports publications.

Skills

IHC knowledge

Scientific writing

Data analysis

Regulatory understanding

Education

Bachelor's or Master's degree in biochemistry, molecular biology, immunology, oncology, pathology, histotechnology, life sciences, or related field

PhD or MD preferred

ASCP certification (plus)

Job description

Build your future with Volt!

Volt is immediately hiring for a Clinical Affairs Scientist in Pacheco, California.

As a Clinical Affairs Scientist, you will:

• 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.

This is a full-time contract opportunity.

The Ideal Candidate will have:

• 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. 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.
• Adheres to SOPs, quality standards, continual improvement principles, and applicable root cause analysis activities.

Pay Range and Benefits

• Pay Range*: $85 - $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 email [e-mail] or call (866) -898-0005. 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.