About this role
- 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. A uthor, 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 IVD s , including software and bioinformatics. Define regulatory requirements for IVD product(s), including s oftware, 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 Research Use Only claims for compliance.
- Manage regulatory risk. Interpret evolving requirements, identify risks early, and recommend practical, science-based paths that protect patients, program objectives , and business priorities
- Bachelor's degree in life sciences, engineering, or a related field .
- At 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.
- Excellent technical writing and communication skills, including the ability to explain complex issues clearly to regulators, partners, scientists, and senior leaders.
- Sound judgment and comfort operating in a growth-stage environment, balancing strategic direction with hands-on execution and managing multiple priorities with limited oversight.
- Companion diagnostic development, particularly oncology programs and coordination of diagnostic and therapeutic regulatory strategies from clinical development through approval.
- Liquid biopsy, epigenomics, oncology diagnostics, or biomarker-driven drug development.
- Global IVD registrations, including familiarity with the European Union In Vitro Diagnostic Medical Devices Regulation and technical documentation expectations.
- Regulatory oversight of software and bioinformatics lifecycle documentation for complex diagnostic products.
- An advanced scientific degree or Regulatory Affairs Certification.
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