Regulatory Affairs Specialist

4 weeks ago


Boston, Massachusetts, United States PathAI Full time

Regulatory Affairs Specialist Role

PathAI is seeking an experienced Regulatory Affairs Specialist to support the development and approval of our diagnostic products. As a key member of our regulatory team, you will work closely with cross-functional teams to ensure compliance with regulatory requirements and guidelines.

Key Responsibilities:

  • Prepare and manage regulatory submissions, including FDA 510(k), PMA, and EMA IVDR filings.
  • Organize technical files, design dossiers, and regulatory documentation for diagnostic products.
  • File pre-submission requests and respond to inquiries from global regulatory bodies.
  • Author/write regulatory documents in support of our submission process.

Requirements:

  • 5+ years of experience in regulatory affairs, with a focus on diagnostic devices and proven experience with FDA and EMA Dx submissions.
  • Expertise in regulatory submissions for in vitro diagnostic devices (IVD), particularly in AI-driven technologies, pathology, and SaMD (Software as a Medical Device).
  • Demonstrated hands-on experience in leading regulatory filings and bringing products to market globally.

What We Offer:

At PathAI, we are committed to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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