Element Biosciences
Director, Regulatory Affairs
San Diego - Headquarters · Director · Full-time
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odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
$24,384 more — $176,384 — moves this role to Level III and 3 lottery entries. That figure is inside the range the employer already advertised.
Based on the DOL prevailing wage for this occupation and worksite, a base salary of $176,384 would place this position at wage Level III. That figure is within the posted range, and I'd like to target it. This role classifies under "Managers, All Other" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Managers, All Other (11-9199) · San Diego-Chula Vista-Carlsbad, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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from this employer's Department of Labor filings
Files H-1B transfers
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment.
- The Director will establish and execute global regulatory strategies supporting product development, market authorization, commercial expansion, strategic diagnostic partnerships, and lifecycle management.
- This role will be an onsite role based in San Diego.
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
- 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
- Own regulatory assessment and governance for product, software, manufacturing, supplier, labeling, and other lifecycle changes affecting marketed products
- Build and scale the Regulatory Affairs function, including people, external resources, governance, processes, systems, regulatory intelligence, and global registration infrastructure
- Experience building or scaling a Regulatory Affairs function, team, operating model, or infrastructure
- Exceptional regulatory judgment, including the ability to assess and prioritize material regulatory and compliance risks and develop pragmatic, defensible solutions
Requirements
- Ability to lift up to 20 pounds
Nice to have
- Minimum bachelor's degree in life sciences, engineering, regulatory affairs, or related discipline
- advanced degree or RAC preferred
- 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
- Proven track record of working well cross functionally and in a collaborative way
- Self-directed, proactive, and embodies an enterprise mindset
Compensation
- $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.
Benefits
- Education and Experience:
- Deep working knowledge of ISO 13485, ISO 14971, post-market requirements, labeling, change control, and applicable medical device/IVD regulatory frameworks
- 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.
Company info
- 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 are committed to scientific integrity, collegiality, honesty, objectivity, and openness.
This listing is sourced directly from Element Biosciences's careers page and normalized into a canonical job model.