Regulatory Affairs Specialist

1 day ago


Boston, Massachusetts, United States PathAI Full time

Job Title: Principal Regulatory Affairs Specialist

We are seeking an experienced Principal Regulatory Affairs Specialist to play a key role in supporting regulatory strategies and ensuring the success of our diagnostic products in the global market.

Key Responsibilities:

  • Regulatory Submissions and Documentation: Prepare and manage regulatory submissions, particularly for FDA 510(k), PMA, and EMA IVDR filings, ensuring technical accuracy and compliance.
  • Compliance and Product Development Support: Provide regulatory expertise and guidance to cross-functional teams (engineering, clinical, quality) during product development, ensuring compliance with relevant standards (FDA QSR, ISO 13485, IVDR, ISO 14971).
  • Regulatory Strategy and Risk Management: Contribute to regulatory strategy development by collaborating with leadership to identify the most efficient pathways for product approval.

Requirements:

  • Experience: 5+ years of experience in regulatory affairs, with a focus on diagnostic devices and proven experience with FDA and EMA Dx submissions (510(k), PMA, IVDR).
  • Expertise: Regulatory submissions for in vitro diagnostic devices (IVD), particularly in AI-driven technologies, pathology, and SaMD (Software as a Medical Device).
  • Education: Bachelor's degree in engineering, physical, or life sciences (Advanced degree preferred).

What We Offer:

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

PathAI is an Equal Opportunity Employer: We are committed to creating a diverse and inclusive workplace that reflects the communities we serve. We welcome applications from qualified candidates who are passionate about contributing to our mission to improve patient outcomes with AI-powered pathology.



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