Backed by 5AM Ventures.
About the role
This is a senior individual contributor role with broad influence across the organization. You will own submissions from strategy through approval, serve as the regulatory lead on cross-functional and partner teams, and translate complex analytical, clinical, software, and bioinformatics evidence into clear regulatory positions. The role is well suited to someone who combines sound judgment with the willingness and ability to draft the work directly. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor's degree in life sciences, engineering, or a related field
- A minimum of 8 years of regulatory affairs experience in medical devices, including substantial experience with IVDs and increasing responsibility for regulatory strategy and submissions
- A demonstrated record of leading and authoring substantial portions of FDA IVD submissions. Direct experience with at least one major premarket pathway, such as 510(k), De Novo, or PMA, is required
- Strong knowledge of US and EU IVD requirements, design and development controls, risk management, and quality system expectations, with the ability to apply requirements to complex scientific and technical questions
- Experience with molecular diagnostics, NGS-based assays, or other complex diagnostics that combine laboratory processes, software, algorithms, and bioinformatics
- Ability to interpret analytical and clinical performance data and determine whether the evidence supports an intended use, claim, or regulatory position
More about this role
The Opportunity
Precede Biosciences is seeking a hands-on Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our products and companion diagnostic programs developed with biopharma partners.
This is a senior individual contributor role with broad influence across the organization. You will own submissions from strategy through approval, serve as the regulatory lead on cross-functional and partner teams, and translate complex analytical, clinical, software, and bioinformatics evidence into clear regulatory positions. The role is well suited to someone who combines sound judgment with the willingness and ability to draft the work directly.
About Precede Biosciences
We are pioneering an advanced, minimally invasive, comprehensive epigenomics platform with the potential to profoundly impact the research and development of new medicines and the use of approved medicines in clinical practice across a number of conditions, including cancer. More information on our company and platform can be found on our company website and in our seminal publication in Nature Medicine.
We care deeply about creating a place where folks can do their best work from the...
Browse similar: Startup jobs