{"id":676746,"url":"https://alion.io/job/cordx-regulatory-affairs-manager-ivd","title":"Regulatory Affairs Manager - IVD","company":{"id":672970,"name":"CorDx","domain":"cordx.com","url":"https://alion.io/company/cordx-2","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":{"grade":"D","score":44,"open_postings":46,"ghost_share":0.935,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":107000,"max_usd":245000,"period":"year","method":"role_country_seniority_unknown","sample_n":1243},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"FDA 510(k)","optional":false},{"name":"Design Controls","optional":true},{"name":"ISO 13485","optional":true},{"name":"ISO 14971","optional":true}],"status":"live","first_seen_at":"2026-08-19T00:00:00Z","employer_posted_date":"2026-08-19","last_verified_at":"2026-11-02T02:24:57Z","board_verified":true,"closed_at":null,"days_open":75,"trust":{"level":"ok","repost_count":0,"flags":["company_stale"],"days_open":74},"description":"CorDx Inc. is seeking an experienced Regulatory Affairs Manager to support the development, registration, and lifecycle management of in vitro diagnostic (IVD) medical devices in the United States.\nThe Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic products, including FDA 510(k), CLIA categorization/waiver activities, and other applicable regulatory pathways. The position will work closely with R&D, Clinical Affairs, Quality, Manufacturing, Product Management, and external partners throughout the product development lifecycle.\nThe ideal candidate has at least five years of regulatory affairs experience in the IVD or medical device industry, with hands-on experience preparing FDA submissions and interacting with FDA.\nCompany: CorDx Inc.\nLocation: San Diego, CA\nDepartment: Regulatory Affairs / Compliance\nEmployment Type: Full-Time\nRegulatory Strategy & Product Development\nDevelop and execute U.S. regulatory strategies for new and existing IVD products.\nDetermine appropriate regulatory pathways, product classification, predicate devices, and submission requirements.\nProvide regulatory guidance to R&D, Clinical, Quality, Manufacturing, and Product teams throughout product development.\nParticipate in design and development activities and provide regulatory input regarding intended use, indications for use, labeling, performance requirements, and regulatory testing.\nConduct regulatory assessments for product changes and determine whether new regulatory submissions or notifications are required.\nFDA Submissions\nLead preparation, review, and submission of FDA regulatory applications, including:\n510(k) Premarket Notifications\nCLIA Categorization and CLIA Waiver submissions\nQ-Submissions / Pre-Submissions\nAdditional Information (AI) responses\nOther FDA submissions and regulatory correspondence as applicable\nPrepare and review regulatory submission sections covering device description, labeling, analytical performance, clinical performance, software, usability, risk management, and other applicable areas.\nCoordinate cross-functional submission activities and ensure submission documents are complete, consistent, accurate, and submitted according to project timelines.\nManage FDA submission timelines, commitments, questions, and responses.\nServe as a regulatory point of contact for communications with FDA reviewers.\nParticipate in FDA meetings, teleconferences, and interactive reviews.\nCoordinate and prepare responses to FDA deficiencies and requests for additional information.\nIVD Performance & Clinical Regulatory Support\nProvide regulatory guidance for analytical and clinical study strategies supporting IVD submissions.\nReview analytical performance protocols and reports, including studies such as:\nLimit of Detection (LoD)\nInclusivity and cross-reactivity\nInterference\nPrecision and reproducibility\nStability\nFlex studies\nMethod comparison\nClinical performance studies\nWork closely with Clinical Affairs to ensure clinical study designs and resulting data meet FDA submission requirements.\nReview clinical performance results, including PPA, NPA, confidence intervals, invalid rates, and other applicable performance measures.\nSupport regulatory strategies for POC and OTC diagnostic products and CLIA Waiver applications.\nLabeling & Lifecycle Management\nReview and approve regulatory aspects of:\nInstructions for Use (IFU)\nPackage labeling\nQuick Reference Instructions\nProduct claims\nMarketing and promotional materials\nEnsure product claims and labeling remain consistent with FDA-cleared intended use and indications.\nMaintain regulatory documentation and submission records.\nSupport post-clearance product changes and regulatory impact assessments.\nMonitor relevant FDA regulations, guidance documents, standards, and industry developments affecting CorDx products.\nCross-Functional & Compliance Support\nPartner with Quality Assurance to maintain compliance with applicable FDA Quality System requirements and internal procedures.\nParticipate in design reviews, risk management activities, CAPA investigations, and change control activities when regulatory input is required.\nSupport FDA inspections and other regulatory audits.\nDevelop and maintain regulatory SOPs, work instructions, templates, and regulatory tracking systems.\nProvide regulatory training and guidance to internal teams.\nMentor junior Regulatory Affairs staff and support development of the regulatory team.\nRequirements\nBachelor’s degree or higher in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory Science, Regulatory Science, Life Sciences, or a related scientific discipline.\nMinimum 5 years of Regulatory Affairs experience in the IVD, medical device, diagnostics, or related regulated healthcare industry.\nHands-on experience preparing and supporting FDA regulatory submissions.\nStrong knowledge of FDA medical device and IVD regulatory requirements.\nExperience reviewing technical documentation, analytical performance studies, clinical performance data, and product labeling.\nDemonstrated ability to manage regulatory projects independently and work effectively across multiple functions.\nExcellent technical writing, analytical, organizational, and communication skills.\nAbility to manage multiple regulatory projects and deadlines simultaneously.\nStrongly Preferred\nDirect experience with IVD products and FDA 510(k) submissions.\nExperience serving as the primary or key regulatory contact during FDA review.\nExperience preparing FDA Additional Information responses and participating in interactive review.\nExperience with CLIA Waiver and/or CLIA Categorization submissions.\nExperience with point-of-care (POC) and/or over-the-counter (OTC) IVD products.\nExperience with infectious disease, respiratory, toxicology, reproductive health, or rapid diagnostic products.\nExperience with FDA Q-Submissions/Pre-Submissions.\nExperience with De Novo submissions is a plus.\nFamiliarity with ISO 13485, ISO 14971, design controls, and applicable FDA Quality System requirements.\nRAC certification is a plus.\nKey Competencies\nRegulatory strategy\nFDA submission leadership\nTechnical and regulatory writing\nAnalytical and clinical data interpretation\nCross-functional leadership\nFDA communication and negotiation\nStrong scientific judgment\nAttention to detail\nProject management\nAbility to work effectively in a fast-paced diagnostic product development environment\nBenefits\nComprehensive medical insurance.\n401(k) plan with generous company contributions.\nFlexible paid time off (PTO) policy.\nEqual Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. 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