Director, Regulatory Affairs
Element Biosciences
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
Vacancy posted 6 days ago
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