Element Biosciences develops genomic sequencing and multiomics technologies used in biological research, drug discovery, and diagnostic applications. Backed by Venrock.
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
More about this role
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...
Browse similar: Startup jobs