Remote Regulatory affairs Jobs · ISO 13485

• Provide regulatory affairs support for FDA medical device compliance, including pre-market submissions (510(k), PMA) and facility registration.
• Coordinate complaint investigations, risk assessments, and field action notifications while ensuring compliance with ISO 13485 and MDR.
• Collaborate with cross-functional teams to prepare documentation, support QMS audits, and maintain regulatory records.

Fujifilm Healthcare Americas Corporation provides cutting-edge healthcare solutions including diagnostic imaging, enterprise imaging, and endoscopic/surgical imaging. With over 70,000 employees globally, the company operates in a dynamic, flexible environment that fuels creativity and collaboration.

• Conduct remote audits of medical device quality management systems against ISO 13485 and EU MDR.
• Review objective evidence, identify findings, and deliver structured audit reports.
• Apply sound regulatory judgement and support continuous improvement of audit processes.

The partner company specializes in assessing innovative health technologies and ensuring regulatory compliance for medical devices. It operates with a quality-focused culture, valuing autonomy and regulatory expertise.

• Lead Quality Systems and Regulatory Affairs to ensure compliance with FDA, ISO 13485, and EU MDR.
• Optimize the electronic Quality Management System (eQMS) and drive sustainable process improvements.
• Serve as primary quality and regulatory representative during audits, inspections, and regulatory submissions.

CEFALY Technology develops medical devices for migraine relief. It is a growing organization that values quality, compliance, and mentorship.