# Director, Regulatory Affairs at Element Biosciences

- Company: Element Biosciences
- What the company does: Element Biosciences develops genomic sequencing and multiomics technologies used in biological research, drug discovery, and diagnostic applications. Backed by Venrock.
- Company website: https://elementbiosciences.com
- Type: Startups
- Level: Principal and up
- Location: San Diego - Headquarters
- Work setup: On-site
- Pay: $152K to $215K base salary per year (USD)
- Posted: 2026-09-21
- Apply by: 2026-11-05
- Apply: https://job-boards.greenhouse.io/elementbiosciences/jobs/6196172004
- Page: https://www.1752.vc/careers/jobs/element-biosciences-director-regulatory-affairs/

## About the role

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.

## What they're looking for

- 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
- 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

Tags: Operations Admin