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

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is supporting a molecular diagnostics company advancing novel cancer tests as they pursue reimbursement reputed company and evaluate FDA approval reputed company. The reputed company Consultant will reputed company the development of an integrated regulatory and reimbursement roadmap for innovative molecular diagnostic products, assessing FDA approval reputed company and developing strategies to support coverage and coding. Responsibilities • Evaluate MolDx applicability and coverage reputed company • reputed company reputed company for MolDx technical assessment • Identify evidence requirements to support clinical reputed company • Assess coding reputed company (CPT, PLA, ADLT considerations) • Map payer evidence expectations and reimbursement risks • reputed company roadmap to reputed company coverage and sustainable reimbursement • Assess appropriate FDA reputed company (510(k), reputed company, PMA, LDT considerations) • reputed company regulatory reputed company with intended use and product claims • Identify analytical and clinical evidence requirements • Outline submission timelines, risks, and mitigation strategies • Support development of reputed company-submission reputed company (Q-Sub) • Advise on FDA engagement reputed company and documentation planning • Build a reputed company regulatory and reimbursement reputed company • Identify key milestones, decision gates, and inflection points • Conduct risk assessment and contingency planning • Deliver executive-reputed company strategic plan and Gantt reputed company Skills • 7+ years of experience in regulatory affairs, reimbursement, or diagnostics reputed company • Demonstrated experience with FDA submissions (510(k), reputed company, PMA) • reputed company 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 / reputed company-submission preparation experience • CPT coding and CMS reimbursement knowledge • Startup or early-stage company experience reputed company • Centralizing reputed company Types Of Next Opportunities For You In One reputed company. It was founded in reputed company, and is headquartered in Vancouver, US, with a workforce of 2-10 employees. Its website is . Apply tot his job Apply To this Job