Technical Analyst

2 weeks ago

Toronto, Canada Global ERP Solutions Full time

We’re looking for a highly experienced Technical Analyst - Healthcare to join our team. With strong regulatory knowledge and hands-on auditing experience across medical devices, software, and healthcare IT systems. This role is critical in ensuring compliance with global standards, maintaining product integrity, and supporting regulatory readiness across the organization.

The ideal candidate brings deep understanding of ISO 13485, FDA regulations, software validation, and IT security frameworks impacting medical devices.

Core Skills:

Conduct comprehensive audits of medical devices, quality systems, and IT infrastructure to ensure compliance with:

- ISO 13485
- FDA 21 CFR Part 820
- IEC 62304
- HIPAA
- Company-specific QMS and IT governance policies

Evaluate risk management processes, including device safety, cybersecurity, and data protection.

Review and assess software validation, data integrity, electronic records, and cybersecurity controls.

Collaborate with cross-functional teams—Engineering, IT Security, Quality Assurance—to identify audit gaps and recommend corrective and preventive actions.

Prepare clear, concise audit reports, summarizing findings, risk levels, and improvement recommendations.

Monitor updates in global regulations and adapt audit protocols accordingly.

Participate in incident investigations, including root cause analysis for device- or IT-related issues.

Support teams during external inspections, certification audits, and regulatory assessments.

Bachelor’s degree in Life Sciences, Engineering, Information Technology, or a related field.

Proven experience auditing medical devices and/or IT systems within healthcare, medical devices, or regulated manufacturing.

Knowledge of risk management, software validation, and data integrity controls.

Excellent analytical thinking, report writing, and communication skills.

Ability to work independently and collaboratively with cross-functional teams.

Must Have: ISO 13485 Certified Lead Auditor.

Nice to Have: CISA, ISO 27001 Lead Auditor, or other recognized certifications.

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