Director, Regulatory Affairs

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

Requirements

• Ability to lift up to 20 pounds

Preferred

• 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

Education and Experience

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

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

Travel

Willingness to travel up to approximately 10% of the time

Job Type

Full-time

Base Compensation Pay Range

$152,000 - $215,000

In addition to base compensation noted above, you will be eligible for stock options, discretionary annual bonus, no cost health insurance plans, 401k with company match, and flexible paid time off.

Please note: Base compensation will depend on multiple factors, including geographic location, qualifications, and experience.

We foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.