Remote QARA Operations Lead for SaMD

Radformation; Remote; CAD 196,000 - 239,000; Full time

Job summary

A healthcare technology company is seeking a QARA Operations Lead to oversee quality and regulatory deliverables in a fully remote environment. The ideal candidate has 5+ years of experience in Quality Systems and familiarity with medical device regulations including CAPA. Responsibilities include managing QARA tasks, coordinating project schedules, and maintaining audit-ready documentation to support product development. This role offers competitive compensation and the opportunity to make a significant impact in the healthcare sector.

Benefits

Competitive salary

Health insurance options

401(k) with employer match

Self-managed PTO

Monthly internet stipend

Fully remote work environment

Qualifications

• 5+ years of Quality Systems experience and Software as a Medical Device (SaMD) experience.
• 3+ years in a project management or technical leadership role.
• Experience working in a regulated agile development environment.

Responsibilities

• Organize and manage timely completion of QARA tasks, including CAPAs and DHF deliverables.
• Coordinate due dates, dependencies, and status updates to align QARA work with project schedules.
• Maintain teamwide deliverable trackers with owners, due dates, and dependencies.

Skills

Quality Systems experience

Software as a Medical Device (SaMD)

Project management

Regulated agile development

Medical device CAPA regulations

Global medical device regulations

ISO 13485

ISO 14971

IEC 62304

GDPR

HIPAA

Tools

eQMS systems

ALM systems

Job description

A healthcare technology company is seeking a QARA Operations Lead to oversee quality and regulatory deliverables in a fully remote environment. The ideal candidate has 5+ years of experience in Quality Systems and familiarity with medical device regulations including CAPA. Responsibilities include managing QARA tasks, coordinating project schedules, and maintaining audit-ready documentation to support product development. This role offers competitive compensation and the opportunity to make a significant impact in the healthcare sector.