Senior Regulatory Affairs Specialist

Meridian 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.

Responsible for supporting Meridian's regulatory and quality processes, including Meridian's product realization process, to ensure that Meridian's activities are consistent with applicable quality and regulatory requirements, especially the design, development and manufacture of medical devices. Assist the regulatory department with product compliance throughout all stages of the product lifecycle, including research, development, transfer, validation/verification, labeling, regulatory submissions, and lifecycle maintenance. Works cross-functionally to ensure that regulatory guidance is provided in support of business objectives.

Tasks/Duties/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.

• 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
• Experience supporting software-enabled medical devices, instrument platforms, firmware-controlled systems, connected devices, or digital health technologies preferred.
• Working knowledge of cybersecurity requirements applicable to medical devices, including vulnerability management, threat modeling, cybersecurity risk assessments, Software Bill of Materials (SBOM), and secure product development practices
• 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.
• Experience supporting Design Control activities for software-enabled medical devices, including requirements management, traceability, risk management, verification, validation, and change control activities preferred.
• 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.
• 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 preferred.
• 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

*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*