{"id":3762279,"url":"https://alion.io/job/meridian-bioscience-regulatory-affairs-specialist","title":"Regulatory Affairs Specialist","company":{"id":2303760,"name":"Meridian Bioscience","domain":"meridianbioscience.com","url":"https://alion.io/company/meridianbioscience","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"junior","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cincinnati, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"FDA 510(k)","optional":false},{"name":"Human Factors Engineering","optional":false},{"name":"IEC 60601","optional":false},{"name":"IEC 62304","optional":false},{"name":"IEC 62366","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"IVDR","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-11-04T18:57:45Z","employer_posted_date":"2026-11-04","last_verified_at":"2026-11-05T15:29:43Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"About Meridian\nMeridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.\nJob Summary\nResponsible for supporting Regulatory Affairs, Design Quality Assurance and software compliance activities for Meridian's in vitro diagnostic (IVD) instruments and associated software throughout the product development lifecycle. This position supports compliance with applicable design control, software lifecycle, risk management, and quality system requirements through the review and assessment of technical documentation, verification and validation activities, and design changes. Works cross-functionally with Software Engineering, R&D, Regulatory Affairs, and Quality Assurance to identify compliance gaps, support remediation activities, and ensure appropriate documentation and objective evidence are maintained within the Design History File (DHF).\nKey Duties\nEnsures that national and international compliance regulations for the design and development of medical devices are met and maintained throughout the lifecycle, including FDA’s QSR (21 CFR Part 820), ISO 13485, MDSAP, IVDR, and others.\nAssists with the preparation, submission, and management of regulatory dossiers, Technical Files, and FDA marketing submissions (510(k) Pre-Marketing Notifications, Pre-Submissions) in accordance with required regulations/standards. \nSupport implementation and maintenance of design controls in accordance with applicable regulatory requirements and internal quality system procedures.\nReview and assess design and development documentation, including User Needs, Product Requirements, Software Requirements Specifications, Design Plans, and Design History Files.\nMaintain regulatory files, information, logs, and databases to ensure data continuity by collecting information and entering it accurately into various applications.\nParticipates in the development and execution of global regulatory strategy in collaboration with interdisciplinary project teams to support compliance with international regulatory and quality system requirements and overall business objectives. \nSupport development and maintenance of Design Traceability Matrices (DTMs), ensuring traceability between design inputs, design outputs, risk controls, and verification and validation activities.\nSupport software lifecycle compliance activities, including review of software documentation, change control, and verification records in accordance with IEC 62304.\nAssist with software cybersecurity documentation and compliance activities, including vulnerability management, risk assessments, and supporting records.\nAssists with the review and approval of product technical documentation (i.e. requirements documents, verifications/validations, Safety Data Sheets, manufacturing procedures, and labeling). \nCompletes evaluation of the regulatory impact of changes associated with product design change. \nAuthor and/or revise regulatory SOPs to align with current regulations and best regulatory practices. \nEnsures that required documentation is properly assembled and maintained per quality system processes and procedures.\nParticipate on long-term projects supporting the business and quality objectives of the organization.\nOther duties as assigned. \nQualifications\nBachelor of Science degree in Biology, Biochemistry, Microbiology or related field with 2 years of experience in\nRegulatory Affairs; Quality Assurance, Quality Systems, Design Control, Regulatory Affairs or equivalent.\nOne year 1 year of direct ISO 14971 Risk Management experience is required, including preparation of Risk Management Plans, Hazard Assessments, Usability Engineering, Human Factors Analysis, etc.\nExperience with design control, product development, validation and verification activities preferred. \nExperience with IVDR is preferred. \nExperience supporting regulatory submissions (e.g., 510(k)s and/or PMAs, and/or international registrations) is strongly preferred.\nHighly motivated, detail oriented, must have a constant awareness of customer requirements and must demonstrate an ability to make fact-driven decisions; maintain accurate and concise records, uphold regulatory and quality system requirements including 21 CFR 820, ISO13485, 2017/746, and SOR/98-282.\nKnowledge with International Registrations, Health Canada, IVDR, ISO13485:2016\nAwareness of technical standards, including IEC 60601, IEC 61010, IEC 62366 for establishing the safety and effectiveness of medical electrical equipment.\nAbility to work independently and identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.\nMust be organized with strong attention to detail and able to prioritize and balance workloads and meet strict critical deadlines along with performing under pressure in a fast-paced environment.\nReadily adapts to changing priorities, effectively manages own time, sets priorities to ensure tasks, multiple projects are prioritized and completed on time.\nMust possess exceptional communication (written and verbal) skills, interpersonal skills, problem solving and ability to interact effectively with all levels of the organization both internally and externally.\nStrong background utilizing MS Office applications (Word, Excel, PowerPoint, Outlook)\nMust be willing to travel as 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