Principal Regulatory Affairs Specialist

5 days ago

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PathAI

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artificial intelligence • pathology • digital pathology • oncology • immuno-oncology

501 - 1000

💰 $165M Series C on 2021-05

Description

• PathAI is seeking an experienced Principal Regulatory Affairs Specialist to support regulatory strategies and ensure the success of diagnostic products globally. • This role involves preparing global product submissions, including PMA, 510(k), UKCA, and IVDR filings. • Work cross-functionally with internal stakeholders, providing regulatory guidance throughout the product development lifecycle.

Requirements

• 5+ years of experience in regulatory affairs, focusing 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, emphasizing 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.