PathAI · 14 hours ago

Principal Regulatory Affairs Specialist

Boston, MA

Full-time

Remote

Senior Level

5+ years exp

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Responsibilities

Prepare and manage regulatory submissions, particularly for FDA 510(k), PMA, and EMA IVDR filings, ensuring technical accuracy and compliance.

Organize technical files, design dossiers, and regulatory documentation for diagnostic products, including AI-driven and IVD devices.

File pre-submission requests and respond to inquiries from global regulatory bodies.

Author/write regulatory documents in support of our submission process.

Oversee regulatory operations, including the management of regulatory documentation, tracking of submissions, reporting, data analysis, and the development of dashboards or metrics to monitor and optimize regulatory processes.

Serve as a key point of contact with regulatory agencies, supporting regulatory submissions, pre-submissions, and addressing questions or additional information requests.

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).

Partner with the Quality team to maintain and improve the quality management system (QMS), ensure alignment with current regulatory standards and best practices for diagnostics and SaMD (Software as a Medical Device).

Stay informed of regulatory updates, advising internal teams on how changes in guidelines may affect regulatory strategies and submissions.

Contribute to regulatory strategy development by collaborating with leadership to identify the most efficient pathways for product approval.

Conduct regulatory risk assessments and provide input on product classifications, design controls, and validation testing.

Monitor evolving global regulatory landscapes, especially related to AI in diagnostics, and advise teams on strategic adjustments as needed.

Work collaboratively across various teams, offering regulatory support throughout the product life cycle, from concept to market approval.

Assist in preparing for and supporting audits and regulatory inspections.

Qualification

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Regulatory AffairsFDA 510(k)PMAIVDRIVD DevicesAI-driven TechnologiesSaMDFDA QSRISO 13485ISO 14971Regulatory DocumentationQuality Management SystemRisk AssessmentsProject Management

Required

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 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, with an emphasis on the US and EU markets.

Experience with US Class III and EU IVDR Class C (high-risk) medical device development.

Knowledge of global regulatory standards, including FDA QSR, ISO 13485, IVDR, and ISO 14971.

Bachelor’s degree in engineering, physical, or life sciences.