Remote Quality & Regulatory Operations Lead

Radformation; Canada; Remote; CAD 192,572 - 233,838; Full time

Benefits offered by this job

Competitive salary

Multiple high-quality medical plan options

401(k) with immediate employer match

Self-managed PTO + 10 paid holidays

Company-issued laptop & home office setup stipend

Job summary

A leading healthcare technology firm is seeking a QARA Operations Lead to oversee quality and regulatory deliverables. This role involves ensuring alignment with product development timelines while coordinating cross-functional collaboration. Ideal candidates will have over 5 years of experience in quality systems and software as a medical device. The position is fully remote and offers a salary range of $140,000–$170,000 USD based on experience.

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 in a regulated agile development environment.

Responsibilities

• Organize and manage QARA tasks including CAPAs and DHF deliverables.
• Coordinate due dates and status updates to align QARA work.
• Maintain team-wide deliverable trackers.

Skills

Quality Systems experience

Software as a Medical Device (SaMD)

Project management skills

Attention to detail

Job description

A leading healthcare technology firm is seeking a QARA Operations Lead to oversee quality and regulatory deliverables. This role involves ensuring alignment with product development timelines while coordinating cross-functional collaboration. Ideal candidates will have over 5 years of experience in quality systems and software as a medical device. The position is fully remote and offers a salary range of $140,000–$170,000 USD based on experience.