[Remote] Strategy Consultant – Regulatory & Reimbursement (Molecular Diagnostics)

Note: The job is a remote job and is open to candidates in USA. Peritia is supporting a molecular diagnostics company advancing novel cancer tests as they pursue reimbursement strategy and evaluate FDA approval pathways. The Strategy Consultant will lead the development of an integrated regulatory and reimbursement roadmap for innovative molecular diagnostic products, assessing FDA approval pathways and developing strategies to support coverage and coding.

Responsibilities
• Evaluate MolDx applicability and coverage pathways
• Develop strategy for MolDx technical assessment
• Identify evidence requirements to support clinical utility
• Assess coding strategy (CPT, PLA, ADLT considerations)
• Map payer evidence expectations and reimbursement risks
• Develop roadmap to achieve coverage and sustainable reimbursement
• Assess appropriate FDA pathway (510(k), De Novo, PMA, LDT considerations)
• Align regulatory strategy with intended use and product claims
• Identify analytical and clinical evidence requirements
• Outline submission timelines, risks, and mitigation strategies
• Support development of pre-submission strategy (Q-Sub)
• Advise on FDA engagement strategy and documentation planning
• Build a unified regulatory and reimbursement timeline
• Identify key milestones, decision gates, and inflection points
• Conduct risk assessment and contingency planning
• Deliver executive-ready strategic plan and Gantt timeline

Skills
• 7+ years of experience in regulatory affairs, reimbursement, or diagnostics strategy
• Demonstrated experience with FDA submissions (510(k), De Novo, PMA)
• Direct MolDx submission and payer engagement experience
• Strong knowledge of IVD, molecular diagnostics, and LDT frameworks
• Experience translating clinical evidence into regulatory and payer value propositions
• Ability to operate independently at a strategic advisory level
• Executive communication and stakeholder engagement skills
• Strong roadmap development and project planning expertise
• Molecular diagnostics or genetic testing background
• Q-Sub / pre-submission preparation experience
• CPT coding and CMS reimbursement knowledge
• Startup or early-stage company experience

Company Overview
• Centralizing All Types Of Next Opportunities For You In One Place. It was founded in undefined, and is headquartered in Vancouver, US, with a workforce of 2-10 employees. Its website is .

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