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Senior Regulatory Affairs Engineer (AI/ML)

On-site Full-time

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Experience Level

Senior

Qualifications

QualificationsEducation: Bachelor’s or Master’s degree in law, medicine, pharmacy, engineering, or a related field. Experience: 4–5+ years of experience in software development with a focus on artificial intelligence and machine learning within the medical device industry.

About the job

Mission

At Neko Health, our mission is to revolutionize healthcare by transitioning from illness treatment to proactive prevention. We leverage innovative, non-invasive technology and clinical expertise to provide early, actionable health insights.

Position Overview

We invite you to join Neko Health as a Senior Regulatory Affairs Engineer. Are you eager to influence the future of medical technology? We are on the lookout for a dedicated professional who excels in navigating complex regulatory frameworks, thrives in a fast-paced, collaborative setting, and is passionate about working with pioneering medical devices.

We seek candidates with extensive expertise in software development, artificial intelligence, and machine learning within the medical device sector.

Key Responsibilities

  • Ensure Regulatory Compliance: Guarantee that our advanced software adheres to global regulatory standards, aligning regulatory strategies from R&D to market launch and post-market activities.

  • Implement AI/ML Regulations: Oversee the integration of regulatory requirements into AI and ML algorithms and device software, ensuring compliance throughout our processes.

  • Support Software Development: Provide regulatory guidance during the software lifecycle, influencing design architecture, risk management, supplier selection, and labeling.

  • Documentation Preparation: Engage in creating essential software documentation for our modules, components, algorithms, and devices as required.

  • Empower Teams: Assist process owners and product teams in incorporating regulatory requirements into our Quality Management System and deliver effective training on compliance and regulatory matters.

  • Stay Informed: Track regulatory trends and provide insights to keep Neko Health at the leading edge of compliance.

Qualifications

  • Education: Bachelor’s or Master’s degree in law, medicine, pharmacy, engineering, or a related field.

  • Experience: 4–5+ years of experience in software development with a focus on artificial intelligence and machine learning within the medical device industry.

About Neko Health

Neko Health is dedicated to transforming healthcare by focusing on prevention rather than mere treatment of illnesses. Our innovative, non-invasive solutions and clinical expertise empower individuals with early and actionable health insights.

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