Associate Director, Regulatory Affairs – IVD

Precede Biosciences

. Lead regulatory strategy and execute US and global IVD regulatory strategies from early development through commercialization .

Posted 10/7/2026full-timeCambridge • Massachusetts • United StatesSenior💰 $175,000 - $220,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading regulatory strategy for IVD products, including authoring FDA submissions and aligning development plans with regulatory requirements. Proficient in managing complex diagnostics and ensuring compliance with US and EU regulations.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA Submission AuthoringIVD Regulatory StrategyMolecular Diagnostics ExpertiseRisk Management Knowledge

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Hard Skills

Regulatory Strategy DevelopmentFDA Pre-Submissions510(k) SubmissionsDe Novo RequestsPMA SubmissionsAnalytical ValidationSoftware Verification and ValidationClinical Performance EvaluationTechnical Documentation ReviewEvidence Generation

Soft Skills

Excellent Technical WritingStrong Communication SkillsSound JudgmentAbility to Manage Multiple Priorities

Certifications & Qualifications

Regulatory Affairs CertificationAdvanced Scientific Degree

Industry Keywords

In Vitro DiagnosticsBiopharma CollaborationsCompanion DiagnosticsLiquid BiopsyOncology DiagnosticsNGS-Based AssaysBioinformatics PipelinesEU IVDR ComplianceQuality System ExpectationsClinical Trial Assay Readiness

About the role

Key responsibilities & impact

Lead regulatory strategy and execute US and global IVD regulatory strategies from early development through commercialization
Author, compile, and drive FDA Pre-Submissions, IDEs, 510(k)s, De Novo requests, PMAs and supplements, and relevant international technical documentation
Lead interactions with FDA, other health authorities, and notified bodies; prepare teams for meetings and convert agency feedback into decisions and development plans
Serve as regulatory lead for biopharma collaborations and companion diagnostic programs
Align diagnostic and therapeutic development plans, clinical trial assay readiness, evidence generation, filing strategy, and labeling considerations
Partner with assay development, computational biology, laboratory operations, quality, and program teams to define analytical and clinical performance studies
Review protocols, reports, and technical documentation covering pre-analytical variables, specimen stability, analytical validation, software V&V, clinical performance, and bridging studies
Define regulatory requirements for IVD products, software, algorithms, and bioinformatics pipelines
Contribute to design and development controls, risk management, document control, and audit and inspection readiness
Evaluate product, design, software, manufacturing, and labeling changes for regulatory impact
Review product communications and Research Use Only claims for compliance
Interpret evolving requirements, identify risks early, and recommend science-based regulatory paths

Requirements

What you’ll need

Bachelor's degree in life sciences, engineering, or a related field
Minimum of 8 years of regulatory affairs experience in medical devices, including substantial experience with IVDs and increasing responsibility for regulatory strategy and submissions
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
Experience with molecular diagnostics, NGS-based assays, or other complex diagnostics combining laboratory processes, software, algorithms, and bioinformatics
Ability to interpret analytical and clinical performance data and determine whether evidence supports an intended use, claim, or regulatory position
Excellent technical writing and communication skills
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, preferred
Liquid biopsy, epigenomics, oncology diagnostics, or biomarker-driven drug development preferred
Global IVD registrations, including familiarity with EU IVDR and technical documentation expectations, preferred
Regulatory oversight of software and bioinformatics lifecycle documentation for complex diagnostic products preferred
An advanced scientific degree or Regulatory Affairs Certification preferred

Benefits

Comp & perks

Performance bonus
Equity participation
Comprehensive health benefits
Inclusive and balanced team environment
Team-oriented workplace with individual initiative, accountability, and delivery