Regulatory Affairs Specialist II - Sarnova - Dublin, Ohio

OverviewThe Regulatory Affairs Specialist II serves as a high impact individual contributor responsible for driving the Company’s compliance with applicable federal, state, and international laws and regulations governing medical devices, pharmaceutical products, and other regulated healthcare products distributed by the Company. This role owns regulatory execution, including product classification, labeling and claims review, post-market surveillance, distribution compliance, and regulatory risk monitoring to ensure products are legally marketed and maintained throughout their lifecycle.The Specialist II acts as a regulatory subject matter expert and trusted advisor to cross-functional partners, proactively identifying risk, implementing controls, and leading corrective actions to protect the Company from enforcement exposure while enabling compliant commercial growth.Hybrid Schedule: M-Th in office, Fri work from homeSarnova is the leading national specialty distributor of health care products in Emergency Medical Services (EMS) and Respiratory Markets and is the industry leader in Revenue Cycle Management within Emergency Medical Services (EMS). The company operates through several market-leading companies including Tri-anim Health Services, the largest specialty distributor of respiratory products, Bound Tree Medical, the largest supplier of EMS products, EMP and Cardio Partners, a full Sudden Cardiac Arrest Solution provider, and Digitech, the leader in EMS revenue cycle management.ResponsibilitiesSummary:The Regulatory Affairs Specialist II serves as a high impact individual contributor responsible for driving the Company’s compliance with applicable federal, state, and international laws and regulations governing medical devices, pharmaceutical products, and other regulated healthcare products distributed by the Company. This role owns regulatory execution, including product classification, labeling and claims review, post-market surveillance, distribution compliance, and regulatory risk monitoring to ensure products are legally marketed and maintained throughout their lifecycle.The Specialist II acts as a regulatory subject matter expert and trusted advisor to cross-functional partners, proactively identifying risk, implementing controls, and leading corrective actions to protect the Company from enforcement exposure while enabling compliant commercial growth.Organizational ImpactAs a Regulatory Affairs Specialist II, you will play a critical role in protecting the Company from regulatory and enforcement risk while enabling compliant commercialization and distribution of regulated products. Your work will directly support audit readiness, regulatory inspections, and the Company’s reputation with regulators, customers, and business partners.Essential Duties And ResponsibilitiesRegulatory Strategy& Product GovernanceLead regulatory classification and product determination activities, including medical device class (I, II, III), OTC vs. prescription status, combination product evaluation, and applicable regulatory pathwaysAssist with FDA establishment registration and product listing activities, including UDI compliance, GUDID submissions, and NDC assignments where applicableMaintain defensible regulatory rationale files for audit and inspection readinessSupplier & Manufacturer OversightLead regulatory due diligence for new manufacturers, contract manufacturers, and suppliersConduct regulatory audits and document findings with clear risk assessments and corrective action expectationsQualify suppliers, including monitoring ongoing compliance of foreign and domestic manufacturersEscalate and manage regulatory nonconformances to resolutionLabeling, IFUs & Claims ReviewServe as primary regulatory reviewer for product labeling to ensure compliance with FDA regulations (21 CFR 801 and 201), including UDI, instructions for use, contraindications, warnings, and required statementsReview promotional materials, websites, distributor sales sheets, training materials, and social media content for regulatory and FTC complianceParticipate in medical/legal/regulatory (MLR) review committee governance and claims substantiation file reviewIdentify, mitigate, and escalate off-label promotion risk, recognizing labeling and claims review as a high-enforcement-exposure areaPost-Market Surveillance & ComplaintsConduct post-market surveillance activities, including Medical Device Reporting (MDR) compliance under 21 CFR 803Manage or support the investigation, documentation, and resolution of product complaints and adverse eventsIdentify and trend regulatory and quality issues reported by customers, sales teams, and operationsPartner with Quality and Operations to implement corrective and preventive actionsDistribution, Import & Export ComplianceLead compliance execution for the Drug Supply Chain Security Act (DSCSA), including serialization, transaction data exchange, and authorized trading partner verificationReview import and export compliance activities, including customs classification, FDA import hold management, and foreign manufacturer verificationManage FDA import holds and recommend resolution strategiesMonitor and manage internal controls governing international shipment eligibilityEnsure distribution practices align with regulatory restrictionsRegulatory Intelligence & Risk MonitoringMonitor FDA warning letters, enforcement actions, and competitor regulatory trendsTrack regulatory changes and assess impact to existing and future productsPrepare for and participate in internal audits, audit defense, and inspection readiness and collaborate cross-functionally to implement corrective actions and process improvementsDevelop and maintain regulatory review standard operating procedures and documentation frameworksAdditional ResponsibilitiesSupport corporate regulatory and compliance goals and related KPIsManage or contribute to special regulatory projects as assignedPerform additional duties as assignedSkills/Experience RequiredEducation: Bachelor’s degree requiredMinimum of 5 years of progressive quality or regulatory experience in the medical device, pharmaceutical industry or life sciences industryDemonstrated familiarity with FDA, state regulations, and ISO 13485Strong individual accountability and ethics: acts with integrity and takes ownership for attitude, behavior and outcomesAbility to interact and communicate professionally and effectively with internal and external customers including regulatory agenciesStrong written and verbal communication skillsWell-developed organizational and cross functional skillsComputer skills to include Microsoft Office applications, with emphasis in database and spreadsheet softwareSkills/Experience PreferredRegulatory Affairs CertificationBlood/biologics experience (BLA familiarity, 21 CFR 600-680, blood establishment registration)Manufacturing regulatory experienceExperience responding to audit or regulatory inspectionsSarnova is an Equal Opportunity Employer. We offer a competitive salary, commensurate with experience, along with a comprehensive benefits package, including 401(k) Plan. EEO/M/F/Veterans/Disabled. Our mission is to be the best partner for those who save and improve patients’ lives. Excellence in delivering upon our mission is dependent upon having a diverse team that is empowered to bring their full, authentic self to work each day. We strive to create a workplace that reflects the communities we serve, and we are passionate about creating an inclusive workplace that promotes and values diversity.