Director, Regulatory Affairs

Element Biosciences • San Diego, CA

23h • Onsite

About The Position

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.

Requirements

• Minimum bachelor's degree in life sciences, engineering, regulatory affairs, or related discipline; advanced degree or RAC preferred
• Typically, 12+ years of progressively responsible medical device or IVD Regulatory Affairs experience, including substantial responsibility for regulated IVD product development, market authorization, and lifecycle management
• Demonstrated experience establishing regulatory strategy for complex diagnostic instruments, IVDs, molecular diagnostics, or similarly complex regulated products
• Experience leading regulatory programs across multiple major jurisdictions, including experience with FDA and/or EU IVDR; experience with both strongly preferred
• Demonstrated ability to advise senior executives and influence product, technical, clinical, quality, and commercial decisions without relying on positional authority
• Experience building or scaling a Regulatory Affairs function, team, operating model, or infrastructure
• Deep working knowledge of ISO 13485, ISO 14971, post-market requirements, labeling, change control, and applicable medical device/IVD regulatory frameworks
• Exceptional regulatory judgment, including the ability to assess and prioritize material regulatory and compliance risks and develop pragmatic, defensible solutions
• Proven track record of working well cross functionally and in a collaborative way
• Self-directed, proactive, and embodies an enterprise mindset

Nice To Haves

• advanced degree or RAC preferred

Responsibilities

• 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 intelligence, and global registration infrastructure
• Represent Regulatory Affairs in product development, portfolio, commercialization, and other enterprise decision making forums

Benefits

• stock options
• discretionary annual bonus
• no cost health insurance plans
• 401k with company match
• flexible paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Director