Director, Regulatory Affairs

At Element Biosciences, we are passionate about our mission to empower the scientific community with more freedom and flexibility to accelerate our collective impact on humanity. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment. We are committed to scientific integrity, collegiality, honesty, objectivity, and openness.

We are seeking an experienced Director of Regulatory Affairs to build and lead Element Biosciences’ regulatory function and establish the regulatory strategies and capabilities required to support the company’s continued expansion into regulated diagnostic markets. Reporting directly to the Chief Supply Chain Officer, this role will serve as Element’s senior regulatory advisor and will be responsible for regulatory strategy across the company’s in vitro diagnostic (IVD), next generation sequencing (NGS), and regulated life science instrumentation portfolio.

The Director will establish and execute global regulatory strategies supporting product development, market authorization, commercial expansion, strategic diagnostic partnerships, and lifecycle management. This individual will work closely with executive leadership and Product, R&D, Clinical, Quality, Operations, Legal, and Commercial teams to ensure regulatory considerations are incorporated early into product and business decisions and that Element appropriately balances regulatory risk, business objectives, and speed to market.

The successful candidate will bring deep IVD and medical device regulatory expertise, demonstrated experience leading complex global regulatory programs across functions and markets, strong regulatory judgment, and the ability to operate as both a strategic leader and hands-on builder in a rapidly growing organization.

This role will be an onsite role based in San Diego.

If you possess the following and want to make a meaningful impact, we invite you to explore this role.

• Own and lead Element’s global regulatory strategy for IVD, NGS, software, and regulated life science instrumentation products throughout development, commercialization, and lifecycle management
• Serve as Element’s senior Regulatory Affairs advisor to executive leadership and cross-functional teams, providing clear recommendations on regulatory pathways, risks, tradeoffs, and business implications
• Establish regulatory strategies early in product development, including intended use, claims, classification, market pathways, evidence requirements, product configuration, and RUO-to-diagnostic considerations
• Lead regulatory strategy and execution for global market authorizations, including the United States, European Union, and other priority international markets
• Lead significant interactions with regulatory authorities, notified/assessment bodies, authorized representatives, and other external regulatory stakeholders
• Establish regulatory strategy and responsibilities for diagnostic partnerships, co-development programs, and other collaborations involving shared or dependent product configurations
• Own regulatory assessment and governance for product, software, manufacturing, supplier, labeling, and other lifecycle changes affecting marketed products
• Provide regulatory leadership for post-market reporting obligations, including vigilance, adverse event/incident reporting, field actions, and emerging regulatory risks
• Establish regulatory governance, decision making, and escalation mechanisms that enable timely, consistent, and well-documented regulatory decisions
• Build and scale the Regulatory Affairs function, including people, external resources, governance, processes, systems, regulatory…