Intelerad · 1 day ago

Regulatory Affairs & Quality Manager

United States

Full-time

Remote

Mid, Senior Level

3+ years exp

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Health CareMedical Device

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Responsibilities

Interface with the FDA, Notified Bodies, Health Canada, and other international regulators.

Stay current with FDA and international medical device regulations.

Maintain up-to-date knowledge of ISO 27001 standards.

Coordinate regulatory compliance for new markets, products, design files, technical files, and 510(k) submissions.

Present regulatory and compliance information and statistics to management.

Oversee the management of QMS, including CAPAs, procedures, documentation, and records.

Participate in activities related to adverse events and recalls, including reporting, notification, and follow-ups.

Collaborate with the Privacy Compliance Manager to address information security or privacy incidents and propose improvement solutions.

Ensure company compliance with processes and training programs.

Conduct and/or coordinate internal audits to ensure compliance with legal, regulatory, and ISO standards.

Provide advice and take action in response to audit findings, making recommendations for information security improvements.

Coordinate third-party audits to assess the effectiveness of information protection controls.

Develop and deliver QMS training materials and provide training as needed.

Support and guide the Regulatory Compliance Specialist on improvement projects related to QMS, ISMS, and regulatory affairs.

Supervise and participate in internal process improvement projects, new process development, and regulatory strategy development.

Collaborate with Privacy and Quality Managers to integrate new regulatory requirements into existing processes.

Implement and support the electronic Quality Management System (eQMS).

Establish an AdPromo review and approval process for the Regulatory Affairs & Quality business unit.

Work on projects for DICOM Grid and supervise and support Inteleshare and Intelescreen projects.

Qualification

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Medical device regulatory experienceISO 13485ISO 9001ISO 27001Process mappingMS OfficeGoogle SuiteVisioAutonomous work abilityProject managementContinuous learning mindsetCollaboration skills