IVD Clinical Affairs Scientist - IHC & EU IVDR

Volt; Martinez (CA); On-site; USD 177,000 - 189,000; 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

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.