Senior Clinical Research Scientist - Device Evaluation & Trials

Abbott; Alameda (CA); On-site; USD 114,000 - 228,000; Full time

Job summary

Abbott is seeking a seasoned clinical affairs professional to organize and conduct performance evaluations for new products and enhancements. You will work with R&D, Regulatory, QA and Marketing to identify user needs and present evaluation results for regulatory submissions.

Responsibilities include protocol development, literature reviews, risk assessment, and writing IFU-related materials while ensuring high-quality, medically accurate documentation for FDA and other agencies.

Qualifications

• Requires a Bachelor’s degree with about 9 years of related experience in clinical affairs or similar.
• Master’s degree is preferred and beneficial for the role.
• Shows deep knowledge of business unit functions and cross-group relationships.
• Recognized as an expert in the work group within a quality system environment.

Responsibilities

• Lead clinical evaluations for new products, enhancements and process changes.
• Serve as the clinical resource on product development teams with R&D, Regulatory, QA and Marketing.
• Develop clinical study protocols and analyze results for regulatory submissions such as FDA.
• Prepare high quality, scientifically sound documents for regulatory review.
• Contribute to risk analysis and health risk assessments associated with devices.

Skills

Clinical evaluation

Regulatory submissions

Literature review

Cross-functional collaboration

Education

Bachelor’s Degree in Biological Science or similar

Master’s Degree preferred

Job description

Abbott is seeking a seasoned clinical affairs professional to organize and conduct performance evaluations for new products and enhancements. You will work with R&D, Regulatory, QA and Marketing to identify user needs and present evaluation results for regulatory submissions.

Responsibilities include protocol development, literature reviews, risk assessment, and writing IFU-related materials while ensuring high-quality, medically accurate documentation for FDA and other agencies.