Be the People part of the Neuro Solution. Apply Today at :

https://jobs.dayforcehcm.com/en-US/natus/CANDIDATEPORTAL/jobs/710

FOR MORE THAN 80 YEARS, Natus has been working in collaboration with clinicians to deliver industry-leading neuro solutions that help providers more easily make sense of the body’s signals.

Engineered with input from those who have lived the care experience, our technology simplifies complex processes and improves accuracy and efficiency. There is a role for everyone who wants to be part of the innovative solutions at Natus Neuro.

Statistical Analyst - Clinical AI Validation

Location: Bergen, Norway

Employment Type: Full-time

About Holberg EEG

Holberg EEG is a Norwegian company owned by Natus Medical Inc., the global leader in EEG and neurodiagnostic solutions. We develop next-generation AI-powered, cloud-based medical device software that integrates with external platforms and meets the highest standards for reliability, scalability, and security.

We operate in a regulated industry, and experience with medical software development or compliance-driven environments is highly valued. Our team is built on the values of Teamwork – Excellence – Integrity – Courage, and we work with cutting-edge technologies to deliver impactful solutions for clinicians and patients worldwide.

Role Overview

As a Statistical Analyst - Clinical AI Validation, you will design statistical plans and strategies for AI based medical devices, execute and document clinical validation studies to support product approvals and market readiness. You will collaborate closely with data scientists, clinical experts, software engineers, and quality/regulatory teams to ensure our devices meet the highest scientific and regulatory standards. 

Key Responsibilities

• Plan, design, and conduct clinical validation studies for medical devices, including AI-based diagnostic tools with focus on statistical techniques and strategies.
• Prepare and maintain clinical validation documentation in line with regulatory requirements (FDA 510(k), EU MDR CE). This includes but is not limited to Clinical Validation Plan, Report and all associated documents
• Work closely with clinical validation team on statistical analysis and representation of validation results.
• Work closely with QA/RA team on extrapolation of data to extended patient population or extended intended use. 
• Contribute to software validation and statistical analysis activities to ensure product robustness and compliance.
• Ensure alignment with quality management frameworks such as ISO 13485.
• Provide input into regulatory submissions and collaborate with the regulatory team.
• Own and maintain clinical validation and software validation documentation throughout the product lifecycle.
• Collaborate across teams (data science, clinical, software development, quality, regulatory) to drive validation efforts.

Requirements

• Master’s or PhD in a relevant scientific, engineering, or clinical field.
• Proven experience in authoring or co-authoring scientific journals and publications.
• Hands-on experience conducting clinical validation studies in the medical device domain.
• Exposure to FDA 510(k), and EU MDR CE approval processes. Exposure to EU AI Act would be preferred. 
• Familiarity with ISO 13485 quality management systems (preferred).
• Strong expertise in software validation and statistical analysis.
• Excellent documentation skills and attention to detail.
• Team player with the ability to work cross-functionally and collaboratively.
• Strong sense of ownership and accountability.

What We Offer

• Opportunity to shape the future of AI-driven medical technologies.
• Work with a multidisciplinary and innovative team.
• Competitive compensation and benefits package.
• Scandinavian-style work culture focused on trust and autonomy.
• Career growth in a highly regulated and impactful industry.