Associate Director, Regulatory Affairs; IVD

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.

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 start and have intentionally created an environment that is defined by purpose, teamwork, and excellence. This means nurturing team spirit, facing challenges together, collaboratively solving complex problems, while also ensuring a strong focus on individual initiative, accountability, and delivery.

• Lead regulatory strategy. Develop and execute US and global IVD regulatory strategies from early development through commercialization, including pathway, intended use, claims, evidence, and sequencing of agency interactions.
• Own submissions end to end. Author, compile, and drive high-quality submissions and responses, including FDA Pre-Submissions, IDEs, 510(k) s, De Novo requests, PMAs and supplements, and relevant international technical documentation (e.g. in support of IVDR CE).
• Represent Precede with regulators. Lead interactions with FDA and other health authorities or notified bodies, prepare teams for meetings, and convert agency feedback into clear decisions and development plans.
• Guide companion diagnostic programs. Serve as the regulatory lead for biopharma collaborations, aligning diagnostic and therapeutic development plans, clinical trial assay readiness, evidence generation, filing strategy, and labeling considerations.
• Shape development plans. Partner with assay development, computational biology, laboratory operations, quality, and program teams to define analytical and clinical performance studies that support the intended use and proposed claims.
• Ensure submission-ready evidence. Critically review protocols, reports, and technical documentation, including pre-analytical variables, specimen stability, analytical validation, software V&V, clinical performance, and bridging studies, to ensure conclusions are accurate and well supported.
• Set expectations and regulatory requirements for IVDs, including software and bioinformatics. Define regulatory requirements for IVD product(s), including software, algorithms, and bioinformatics pipelines used in regulated products or in data supporting diagnostic and therapeutic submissions.
• Embed regulatory requirements in the quality system. Contribute to design and development controls, risk management, document control, and audit and inspection readiness in alignment with FDA's Quality Management System Regulation, ISO 13485, ISO 14971, and CLIA and CAP requirements as applicable.
• Assess changes and communications. Evaluate product, design, software, manufacturing, and labeling changes for regulatory impact, and review product communications and…