Meridian Bioscience Inc. · 2 weeks ago
Sr. SW Compliance Specialist – Regulatory Affairs & Design Assurance
United States
Full-time
Remote
Senior Level
4+ years expMeridian Bioscience, Inc. is a fully integrated life science company that develops and distributes innovative diagnostic products. The Sr. SW Compliance Specialist will support regulatory and quality processes to ensure compliance with applicable requirements throughout the product lifecycle, working cross-functionally to provide regulatory guidance.
BiotechnologyHealthcareMedical DeviceLife ScienceHealth CareHealth DiagnosticsMedical
Responsibilities
Provides support and guidance to quality and regulatory activities, including Design Control activities, project teams, design transfer activities, clinical trials, validation and verification activities, and existing product modifications
Supports and helps draft sections of regulatory submissions for domestic, world-wide commercialization and other business objectives
Drafts, evaluates, and reviews technical protocols and data in support of clinical trials, software verification and validation, cybersecurity testing, product validation activities, and product manufacturing
Reviews software architecture, software requirements, traceability, verification and validation documentation, and cybersecurity documentation to support regulatory submissions and quality system requirements
Provides direct support associated with adverse events, medical device reportable events and product recall activities, including corrections and removals
Supports cybersecurity compliance activities, including vulnerability management, threat modeling, Software Bill of Materials (SBOM) review, cybersecurity risk assessments, and FDA cybersecurity documentation requirements
Drafts and reviews, and helps provide guidance for product labeling activities, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards
Provides regulatory input and oversight to product lifecycle planning, including software risk management, cybersecurity risk management, and product risk management activities , and monitors product lifecycle and compiles information associated with changes as directed
Supports software-related regulatory strategies and global regulatory compliance activities throughout the product lifecycle
Participates in design reviews, change assessments, and risk management activities to identify regulatory and compliance impacts associated with software-enabled medical devices
Compiles new product technical information and feature summaries in support of market expansion including software functionality, cybersecurity features, connectivity capabilities, and software-controlled device functionality
Responds to Sales & Marketing requests to ensure content of collateral and promotional materials is compliant with applicable regulations
Participates in long-term projects supporting the business and quality objectives of the organization
Interprets and applies evolving domestic and international regulations, standards, guidance documents, and industry best practices related to software, cybersecurity, artificial intelligence, and digital health technologies
Assists in the management of third-party and internal Quality Audit programs and performs supplier audit, verification, and software-related supplier oversight activities, including oversight of software development suppliers and cybersecurity service providers
Other duties as assigned
Qualification
Required
Bachelor of Science degree in Biology, Biochemistry, Microbiology, Software Engineering, Computer Science, Computer Engineering, Biomedical Engineering, Electrical Engineering, or other related scientific, engineering, or technical discipline required
A minimum of 4–6 years of direct Regulatory Affairs, Design Assurance, Software Quality, or related regulated industry experience is required, including preparation of Pre-IDEs, 510(k) applications, EU Technical Files, Canadian Class II and III licenses, STED documentation, and/or software-enabled medical device regulatory submissions
Prior experience in FDA/ISO regulated industry; Quality Assurance, Quality Systems, Design Control, Regulatory Affairs or equivalent
Knowledge of medical device software lifecycle processes, software development methodologies, software validation principles, and software design controls
Proven knowledge of FDA and ISO regulated environment (Medical Devices, Pharmaceuticals, In Vitro Diagnostic Medical Devices), including risk management principles (e.g. ISO 14971)
Experience with design, development, and clearance of medical devices
Knowledge of FDA software documentation requirements and regulatory expectations for software-enabled medical devices
Experience reviewing software lifecycle documentation, including software requirements, architecture, traceability, verification, validation, and software risk management documentation
Ability to assess software, firmware, cybersecurity, and connectivity changes for regulatory impact and determine applicable submission and reporting requirements
Knowledge of software change assessment methodologies and regulatory decision-making associated with software modifications, cybersecurity updates, bug fixes, anomaly corrections, and feature enhancements
Highly 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 Part 820, ISO 13485, EU IVDR (EU 2017/746), and applicable Canadian Medical Device Regulations
Ability to effectively communicate and translate technical software concepts, risks, and requirements across Engineering, Quality, Regulatory, and business functions
Demonstrated leadership, project management, organizational, and prioritization skills with the ability to manage multiple projects, adapt to changing priorities, meet critical deadlines, and perform effectively in a fast-paced regulated environment
Must 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
Ability to speak in large groups and actively engage participants
Strong background utilizing MS Office applications (Word, Excel, PowerPoint, Outlook)
Preferred
Experience supporting software-enabled medical devices, instrument platforms, firmware-controlled systems, connected devices, or digital health technologies
Experience supporting Design Control activities for software-enabled medical devices, including requirements management, traceability, risk management, verification, validation, and change control activities
Working knowledge of applicable software and cybersecurity standards and guidance documents, including IEC 62304, IEC 81001-5-1, FDA Cybersecurity Guidance, FDA Software Guidance, and related international standards
Company
Meridian Bioscience Inc.
Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic test kits, rare reagents, specialty biologicals and components.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$9MKey Investors
National Institutes of Health
2022-07-07Acquired
2022-01-31Grant· $2.5M
2021-02-03Grant· $5.5M
Leadership Team
Andy Kitzmiller
Chief Executive Officer
J
Julie Smith
Chief Financial Officer
Recent News
2026-07-14
Google Patent
2026-03-01
Company data provided by crunchbase