QA/RA Project Manager

Job Summary

A company is looking for a QA/RA Project Manager.

Key Responsibilities

• Lead QARA integration across product development phases, ensuring compliance and quality standards
• Collaborate with Regulatory Affairs for audits, submissions, and risk management activities
• Facilitate cross-functional coordination to resolve project blockers and provide updates to stakeholders

Required Qualifications, Training, and Education

• 5+ years of program management experience in regulated industries, preferably in SaaS or health tech
• Strong knowledge of healthcare quality and regulatory standards such as ISO 13485 and FDA regulations
• Experience with quality tools and methodologies, including FMEA and CAPA
• Bachelor's Degree required
• Proficiency in project management tools like SmartSheet and Jira preferred