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We are seeking a Regulatory Affairs Principal to play a key role in advancing our pipeline, including the BreathID platform—a unique combination product at the intersection of pharmaceuticals and diagnostics. The Regulatory Affairs Principal will provide strategic regulatory leadership to support the development, approval, and lifecycle management of pharmaceutical and combination drug-device products.

<h2>About Meridian</h2>Meridian Bioscience is a fully integrated life science company developing and delivering innovative diagnostic and life science solutions that improve patient outcomes worldwide. Our work spans discovery to diagnosis, and we are expanding into combination drug-device products that redefine how diseases are detected and managed. We are seeking a Regulatory Affairs Principal to play a key role in advancing our pipeline, including the BreathID platform—a unique combination product at the intersection of pharmaceuticals and diagnostics. <h2>Job Summary</h2>The Regulatory Affairs Principal will provide strategic regulatory leadership to support the development, approval, and lifecycle management of pharmaceutical and combination drug-device products. This individual will serve as a key regulatory partner to cross-functional teams, with a primary focus on FDA CDER interactions, IND/NDA submissions, and global regulatory strategy.This is a high-impact role for a regulatory professional who thrives in a collaborative environment and wants to shape regulatory strategy for innovative combination products.<h2>Key Duties</h2> <ul><li>Lead and contribute to regulatory strategy for pharmaceutical and combination products across development and lifecycle stages</li><li>Author and review INDs, NDAs, supplements, and other global regulatory submissions</li><li>Serve as a primary interface with FDA CDER, including leading preparation for and participation in agency meetings (e.g., Type B/C)</li><li>Develop and deliver high-quality briefing documents, responses, and regulatory communications</li><li>Provide regulatory guidance on clinical, nonclinical, and CMC development activities</li><li>Drive combination product regulatory strategy, including coordination with FDA’s Office of Combination Products (OCP)</li><li>Advise on labeling strategy, including prescribing information and device components of combination products</li><li>Assess regulatory impact of development and post-approval changes and define appropriate regulatory pathways</li><li>Support global regulatory activities, including submissions and interactions with ex-U.S. health authorities (e.g., EMA)</li><li>Stay current on evolving regulatory requirements and translate them into actionable guidance for teams</li><li>Mentor and provide guidance to junior regulatory team members</li></ul> <h2>Qualifications</h2> Experience<ul><li>7+ years of regulatory affairs experience in pharmaceuticals, biotechnology, or combination products </li><li>Proven experience with FDA CDER submissions, including INDs, NDAs, and/or supplements </li><li>Demonstrated success interacting with FDA, including meeting preparation and regulatory strategy execution </li><li>Experience with combination products (drug-device) strongly preferred </li><li>Working knowledge of U.S. regulatory requirements (21 CFR 210/211, Part 4) and relevant FDA guidance </li><li>Exposure to global regulatory environments (e.g., EMA, ICH) preferred</li></ul>Education<ul><li>Bachelor’s degree in a scientific discipline required </li><li>Advanced degree (MS, PhD, PharmD) preferred</li></ul>Certifications<ul><li>RAC (US or Drugs) preferred</li></ul>Travel <ul><li>0-10%</li></ul>

Meridian Bioscience is a fully integrated life science company that manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and biopharmaceutical enabling technologies that help deliver answers. Our products provide accuracy, simplicity and speed for the early diagnosis and treatment of common medical conditions, such as C. difficile, H. pylori, foodborne diseases and respiratory infections.

In addition, we develop and manufacture a variety of biological and non-biological materials used in proficiency testing programs. 

Meridian diagnostic products are used outside of the human body and require little or no special equipment. We design our products to enhance the well being of the patient&mdash;while reducing the total outcome costs of healthcare. 

Meridian has strong market positions in the areas of gastrointestinal infections, serology, parasitology and fungal disease diagnosis. We actively market our products to hospitals, reference laboratories, research centers, physician offices and diagnostics manufacturers in more than 60 countries around the world. 
 <a itemprop="url" mns_rt="Company" target="_blank" href="http://www.meridianbioscience.com/proficiency-and-controls/">Learn more about Meridian Bioscience </a>

Meridian Bioscience

Regulatory Affairs Principal, Pharmaceutical and Combination Products

As the Principal Enterprise Architect, you will report to the Senior Director of Technology and lead a team of talented architects to set a pragmatic architecture vision that will accelerate our Digital Transformation initiatives. Knowledge of business ecosystems, SaaS, infrastructure as a service (IaaS), platform as a service (PaaS), service-oriented architecture (SOA), APIs, and event-driven IT.

POSITION SUMMARY: A deep technical generalist that can rapidly adapt to the pace of business changes and steer the enterprise towards the future technology vision. As the Principal Enterprise Architect, you will report to the Senior Director of Technology and lead a team of talented architects to set a pragmatic architecture vision that will accelerate our Digital Transformation initiatives. In this role, you will work closely with engineering, security, and application & data managers to create and manage an architectural road map to advance strategic initiatives for the institution. This role requires strong individual technical skills as well as people management experience. Position: Principal Enterprise Architect Department: ITS Network/Tech Support Schedule: Full Time ESSENTIAL RESPONSIBILITIES / DUTIES: <ul><li>Own technical architecture and help set vision for the enterprise to drive innovation and transformation</li><li>Define and manage an actionable target state architecture encompassing business, technical and information architectural disciplines</li><li>Develop and manage a comprehensive architecture governance program to enable standards that can be applied across business, engineering, and operations</li><li>Lead the establishment and adoption of architecture processes, principles, standards and patterns to reduce technical debt, drive efficiency, scale and stability, while embracing agility and innovation.</li><li>Research, evaluate, and prototype new methodologies, emerging technologies, and products to advance the target state architecture vision based on industry trends</li><li>Work with business, application owners/managers to understand the business strategy and vision to create innovative solutions to solve the business problems</li><li>Work with architects and engineers to develop proof of concepts/technology and development frameworks that can be leveraged by engineering teams</li><li>Advise on enterprise architecture landscape, including technology, data, security, and integration </li><li>Implement large-scale, innovative IT solutions to drive business transformation</li><li>Transform baseline architecture to target architecture, and ensure the targeted transformation is executed as planned</li><li>Knowledge of business ecosystems, SaaS, infrastructure as a service (IaaS), platform as a service (PaaS), service-oriented architecture (SOA), APIs, and event-driven IT</li><li>Estimate complex IT projects, including assumptions, risks, issues, improvements, and dependencies</li><li>A systems problem solver, able to move fluidly between high-level abstract thinking and detailed implementation</li></ul> JOB REQUIREMENTS EDUCATION: <ul><li>Bachelor's degree in Computer Science, Engineering, or related discipline; equivalent experience acceptable.</li></ul> EXPERIENCE: <ul><li>Must have at least 3-5 years previous experience in managing enterprise architecture teams and delivering complex IT Projects </li><li>Must have at least 6-10 years prior work experience as an Enterprise Architect, Senior Manager, or Director in a complex environment </li><li>Healthcare background a plus</li></ul> KNOWLEDGE AND SKILLS: <ul><li>Strong understanding and experience in leading Digital transformation and modernization initiatives</li><li>Experience in Hybrid Cloud environments</li><li>Experience in AWS: Migrating from Data Center. Building cloud native solutions using AWS managed services.</li><li>Microsoft Active Directory, ADFS, Azure AD, DHCP/DNS</li><li>Operation Systems: Windows, Linux</li><li>Knowledgeable in virtualization: VMWare ESX or Citrix</li><li>Knowledge of Networking: Network protocols, LAN/WAN, SD-WAN, Network and Application Load Balancers, Next Generation Firewalls, Network segmentation</li><li>Knowledge of Security: Security protocols, identity and access management, data encryption, Web Application Firewalls</li><li>Knowledge of HiTrust / HIPAA is a plus.</li><li>Knowledge of CloudFormation, JSON, YAML, Github and fully automated deployments with Infrastructure as Code (IaC)</li><li>Recognized leader with technical teams, broad technical knowledge, and considered an expert in multiple technical subjects. </li><li>Effective listener with strong verbal and written communication skills, able to interact and communicate effectively with all levels of associates and leadership</li><li>Strong understanding of business and system complexity, and project interdependencies, from functional, logical, and technical perspective</li><li>Ability to collaborate with project stakeholders, including business, security, application, data, and infrastructure groups on defining an architecture</li><li>Ability to create process flows, use case models and related diagrams using system modelling tools, such as Microsoft Visio, Lucidchart, etc.</li></ul> Req id: 29972

Boston Medical Center

Principal Enterprise Architect

Appvault

FEED

OTHER

We are looking for an experienced software engineer to help us build a new generation of transpilation tools enabled by AI and modern verification techniques — bridging the gap between algorithm development and deployment to embedded systems. Our platform accelerates deployment of DSP, RF, communications, and embedded signal processing algorithms onto heterogeneous compute targets, including GPUs, FPGAs, ASICs, and edge SoCs.

About Code MetalCode Metal is redefining code translation for mission-critical industries, helping partners move more quickly and reliably from algorithm to silicon. Our platform accelerates deployment of DSP, RF, communications, and embedded signal processing algorithms onto heterogeneous compute targets, including GPUs, FPGAs, ASICs, and edge SoCs. We support automotive, aerospace, defense, and semiconductor partners deploying complex algorithms onto constrained hardware with speed and rigor.The RolesWe are looking for an experienced software engineer to help us build a new generation of transpilation tools enabled by AI and modern verification techniques — bridging the gap between algorithm development and deployment to embedded systems.In this role you will lead the architecture and implementation of novel code generation pipelines that combine Generative AI, Static Analysis, and Formal Verification to translate code written in one language to another. We are open to two distinct backgrounds for this role:Path A — Compiler / ToolingYou have built a compiler, interpreter, or substantial build tooling (e.g. a Cargo-like build system, a Clang plugin, an LLVM pass, a transpiler). You understand ASTs, IR design, and the full compilation pipeline.Path B — AI Agentic ProductYou have shipped a production AI agentic system — orchestrating LLMs with tool use, state machines, retrieval, or multi-step reasoning pipelines. You know where these systems break and how to make them reliable.If you fit either profile and are excited by the intersection of AI and systems programming, we want to talk.Responsibilities<ul><li>Define software architecture for Agentic AI pipelines — including state machines, orchestration layers, and LLM-integrated workflows.</li><li>Build well-tested, extensible code foundations for code translation products, with a focus on correctness and maintainability.</li><li>Collaborate with domain specialists to incorporate formal verification and static analysis methods into the code generation pipeline.</li><li>Partner with software engineering and research teams to build robust code repositories and CI/CD processes.</li><li>Architect and implement complex workflows spanning code parsing, semantic analysis, AI-assisted generation, and output validation.</li></ul>RequirementsMust have<ul><li>7+ years of collaborative enterprise-level software development in C++ or Python, delivering products to a large customer base.</li><li>Demonstrated experience gathering requirements from stakeholders and translating them into software designs.</li><li>Track record of planning and executing large projects in a team-based setting.</li><li>Strong software delivery fundamentals: code review, testing, CI/CD, release management, and build systems.</li></ul>Plus one of the followingCompiler / tooling background:<ul><li>Hands-on experience building a compiler, transpiler, or substantial build tooling (e.g. a Cargo-equivalent, a custom linker, a language runtime).</li><li>Deep familiarity with compiler infrastructure — Clang, LLVM, MLIR, or equivalent.</li><li>Understanding of parsing, AST design, IR transformations, and code generation backends.</li></ul>AI agentic product background:<ul><li>Shipped production AI agentic systems — LLM orchestration, tool-use pipelines, multi-step reasoning, or autonomous code generation.</li><li>Experience building reliable, observable AI workflows with structured outputs, retry logic, and evaluation frameworks.</li><li>Familiarity with ML tools and frameworks (PyTorch, Hugging Face, LangChain, or similar).</li></ul>Great to Have<ul><li>Experience with advanced software verification techniques such as fuzzing, symbolic execution, or formal verification (e.g. TLA+, Coq, Z3).</li><li>Hands-on experience with embedded, heterogeneous (FPGA and/or GPU), or distributed systems.</li><li>Familiarity with DSP, RF, communications, or other compute-intensive domains.</li><li>Experience optimizing and deploying software on constrained or specialized hardware.</li><li>Current security clearance, or ability to obtain one (US Citizenship required for cleared work).</li></ul>Benefits<ul><li>Competitive compensation at the upper end of market range — specific band shared during screening.</li><li>100% employer-paid health care premiums: medical, dental, and vision.</li><li>401(k) with 5% company match.</li><li>Uncapped paid time off, plus sick leave and public holidays.</li><li>Flexible hybrid or remote work arrangement.</li><li>Relocation assistance for qualifying employees.</li></ul>We are an equal opportunity employer. US Citizenship may be required for certain project assignments involving security clearance.

Code Metal

Senior / Principal Software Engineer (Compiler & AI Tooling)

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Regulatory Affairs Principal, Pharmaceutical and Combination ProductsMeridian Bioscience

Principal Enterprise ArchitectBoston Medical Center

Senior / Principal Software Engineer (Compiler & AI Tooling)Code Metal

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