Director, Regulatory Affairs Job at Element Biosciences, San Diego, CA

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  • Element Biosciences
  • San Diego, CA

Job Description

Element Biosciences seeks an experienced Director of Regulatory Affairs to establish and lead the company's regulatory function for in vitro diagnostics, next-generation sequencing, and life science instrumentation. Reporting to the Chief Supply Chain Officer, this role will develop global regulatory strategies, manage market authorizations, and build regulatory capabilities across a rapidly expanding organization.

Responsibilities

  • Develop and execute global regulatory strategies for IVD, NGS, software, and instrumentation products
  • Advise executive leadership on regulatory pathways, risks, and business implications
  • Lead market authorization efforts across US, EU, and priority international markets
  • Manage interactions with regulatory authorities, notified bodies, and external stakeholders
  • Build and scale the Regulatory Affairs function with appropriate staff and infrastructure

Requirements

  • Deep expertise in IVD and medical device regulatory affairs
  • Demonstrated experience leading complex global regulatory programs
  • Strong regulatory judgment and strategic decision-making ability
  • Experience with market authorization processes in US, EU, and international markets
  • Ability to lead cross-functional teams and advise executive leadership
  • Knowledge of NGS, software, and diagnostic instrumentation regulation

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