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Remote Senior Quality Assurance Analyst - Regulatory Affairs

at Intelerad

Posted 3 days ago

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Description:

  • Responsible for driving quality and compliance excellence across Intelerad’s Software as a Medical Device (SaMD) portfolio.
  • Execute core QA/RA processes including CAPA, audit readiness, supplier oversight, and regulatory support.

Requirements:

  • Bachelor’s degree in a scientific, engineering, or healthcare-related field, or equivalent industry experience.
  • 4+ years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
  • Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 risk management principles.
  • Proven experience managing CAPA, audits, and supplier quality processes.

Benefits:

  • Opportunity to work in a recognized company with a focus on improving patient outcomes.
  • Engage in continuous learning opportunities including training and conferences.

Job title

Other

Job type

Full-time

Experience level

Senior

Required experience

4 years

Salary

$82,500—$110,000 / year

Degree requirement

Degree required

Skills

Flow Agile R Ada

Location requirements

United States

Benefits

-

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