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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