--- title: 'Director, Regulatory Affairs at Element Biosciences' canonical: 'https://feeny.ai/job/director-regulatory-affairs-element-biosciences-san-diego-rkwb1fc4a79y' type: 'job' last_seen: '2026-10-19' --- # Director, Regulatory Affairs at Element Biosciences - **Company:** Element Biosciences - **Location:** San Diego, CA - **Posted:** 2026-09-21 - **Last confirmed live:** 2026-10-19 - **Apply:** https://job-boards.greenhouse.io/elementbiosciences/jobs/6196172004 ## Job description 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. Essential Functions and 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 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 - 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 Physical Requirements: - Ability to lift up to 20 pounds Location: - San Diego/On-site 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. ## About Element Biosciences ## Company Overview - **One-liner**: Element Biosciences develops affordable, high-quality DNA sequencing and multiomics platforms to democratize access to advanced biological analysis. - **Entity Type**: Private (Series E) - **Headquarters**: San Diego, California, USA - **Founded**: 2017 - **Founders**: Three scientists (names not publicly listed in detail, but described as industry veterans) ## Core Business - Primary industry/industries: Genomics, Biotechnology, Life Sciences, Multiomics - Target customers: Research laboratories (academic, government, and biopharma), clinical researchers, and diagnostic developers (B2B, primarily research and clinical segments) - Mission or purpose statement: “To empower the scientific community with more freedom and flexibility to accelerate our collective impact on humanity, and open the world of biology to new possibilities.” [elementbiosciences.com/about](https://www.elementbiosciences.com/about) ## Products & Services - **[AVITI™ System]**: A benchtop DNA sequencing system that delivers high-quality, affordable sequencing (the company announced a $200 genome). Uses proprietary Avidity™ chemistry. - **[AVITI24™]**: A 5D multiomics system launched in April 2024 that provides subcellular spatial co-detection of RNA, protein, and morphology on a single integrated platform, with no library prep required. Powered by ABC Sequencing. - **[VITARI™]**: A new platform/product line announced for scaling without the premium price (details emerging). - **Reagent & Consumables**: Proprietary reagents with a price guarantee for the lifetime of the AVITI system. - **Loop Genomics Acquisition**: Integrated long-read sequencing capabilities via the 2022 acquisition of Loop Genomics. ## Market Standing - **Valuation/Market Cap**: Not disclosed (private company). Total known funding exceeds $553M across multiple rounds. - **Key Metric (Total Funding)**: $277M in Series D (led by Wellington Management), $276M in Series C, plus Series A & B from Foresite Capital and Venrock. An upsized Series E was announced in 2026 to accelerate global growth. [elementbiosciences.com/about](https://www.elementbiosciences.com/about) - **Notable Investors/Partners**: Wellington Management, Foresite Capital, Venrock. Global distribution partners signed in 2023. Nearly 30 unique patents. - **Growth Signals**: - Customer base spanning 40+ countries. - Technology used in 400+ publications. - Achieved ISO 13485 certification (June 2026), establishing a quality foundation for diagnostic applications. - Opened new headquarters at the Alexandria Tech Center in San Diego. - Upsized Series E financing in 2026 to expand genomic, multiomic, and clinical research solutions. ## Competitive Advantages - **Cost Disruption**: The company’s core differentiator is making high-quality sequencing affordable (e.g., the $200 genome) and accessible to labs of all sizes, challenging incumbents like Illumina. - **Integrated Multiomics**: The AVITI24 platform is a first-of-its-kind 5D system that combines sequencing with spatial protein and RNA detection in a single workflow, eliminating the need for library prep. - **Reagent Price Guarantee**: A lifetime reagent price guarantee on the AVITI system provides cost predictability for customers. - **Founding Team & IP**: Founded by industry veterans with deep domain expertise, supported by a strong patent portfolio (30 patents). ## Strategic Focus - **Global Commercial Expansion**: Scaling sales and support infrastructure across 40+ countries, with specific focus on APJ and EMEA regions (as seen in job postings for Field Applications Scientists and Territory Managers in those regions). - **Clinical & Diagnostic Entry**: Leveraging ISO 13485 certification to move into regulated diagnostic applications. - **Ecosystem Expansion**: Building out the AVITI24 multiomics platform and the VITARI scaling platform to capture a broader share of the multiomics and clinical research markets. - **Talent Acquisition**: Actively hiring across R&D, Commercial, Operations, and Quality functions to support rapid growth. ## Why Work Here - **Culture & Values**: The company emphasizes five core values: “We Disrupt the Norm,” “We Lead with Respect,” “We Overcome Challenges with Grit,” “We Own Our Success and Failures,” and “We Embrace Authenticity.” They describe a culture of accountability, transparency, and collaboration. - **Compensation & Benefits**: - 100% company-paid medical, dental, and vision coverage. - Premier mental health care (Spring Health partnership). - $10,000 fertility benefit. - Paid parental leave. - 401(k) match and stock options. - Paid flexible time off (FTO) for both exempt and non-exempt employees. - Free access to local Alexandria EXOS gyms. - Pet insurance and identity theft protection. - **Work Model**: Roles range from onsite (San Diego HQ) to fully remote (APJ, Canada, France). The company has a paid, 10-week onsite summer internship program with a 4.86/5 intern satisfaction rating. - **Growth Opportunity**: Joining a fast-growing, well-funded private company at a pivotal moment of commercial scaling and product expansion, with a mission-driven focus on accelerating science. ## Sources 1. [elementbiosciences.com](https://www.elementbiosciences.com/) 2. [elementbiosciences.com/about](https://www.elementbiosciences.com/about) 3. [elementbiosciences.com/careers](https://www.elementbiosciences.com/careers) 4. [job-boards.greenhouse.io/elementbiosciences](http://job-boards.greenhouse.io/elementbiosciences) 5. 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