Regulatory Affairs Specialist in Medical Devices

Join Clarius as a Regulatory Affairs Specialist to enhance medical imaging solutions.

Your role focuses on regulatory strategy and documentation related to AI/ML technologies.

This fixed-term contract position supports the Data Science and Regulatory Affairs teams ’ll translate complex machine learning methodologies into compliant regulatory documentation while ensuring all submissions meet high standards and regulations for medical devices. Your contributions will significantly impact medical imaging accessibility and quality.

Key Responsibilities:

• Collaborate on defining regulatory strategies for AI-enabled products

• Maintain comprehensive documentation of machine learning processes

• Create regulatory submission materials and documentation

• Support the RA team in technical submissions to regulatory bodies

• Manage documentation updates and version control

Requirements:

• 5+ years' experience in Medtech or regulated industry

• Familiarity with ISO 13485 and FDA compliance

• Degree in a relevant field or equivalent experience

• Detail-oriented with strong documentation and narrative skills

• Effective communicator with cross-functional teams

Bring your regulatory expertise to Clarius and help revolutionize medical imaging for better global healthcare.
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