Regulatory Affairs Spec

Senior International Regulatory Affairs Specialist

The Senior International Regulatory Affairs Specialist is responsible for leading and executing international registration activities, global regulatory strategies, submissions, registrations, regulatory intelligence, change management assessments, and compliance activities for in ASR, RUO and In vitro diagnostic (IVD) devices throughout the product lifecycle. The role develops and maintains country-specific submission strategies, prepares and maintains reusable Global Dossiers, coordinates country-specific submission packages, and supports the transition and traceability of legacy regulatory documentation to applicable legal-manufacturer documentation.

This position collaborates closely with Country Regulatory Affairs, Research & Development, Quality Assurance, Manufacturing, Clinical Affairs, Medical Affairs, Marketing, Legal, and other cross-functional stakeholders to ensure products comply with applicable global regulatory requirements and maintain uninterrupted market access. The specialist is responsible for maintaining existing country licenses and registration records, supporting new registrations, renewals, amendments, change notifications, and regulatory maintenance activities, while assessing product, manufacturing, labeling, software, supplier, and documentation changes for regulatory impact.

The role supports the preparation and maintenance of technical documentation, Global Dossiers, regulatory submissions, and registration strategies, while monitoring evolving regulatory requirements, interpreting regulatory intelligence, and translating regulatory changes into actionable business recommendations. The position requires the ability to independently evaluate regulatory requirements and risks, identify project dependencies and registration gaps, provide strategic and practical regulatory guidance, and drive complex regulatory deliverables to completion.

Operating with a high degree of independence, the Senior International Regulatory Affairs Specialist serves as a key regulatory partner in sustaining compliance, supporting business objectives, and enabling successful global commercialization of products.

· Develop, maintain, and support global regulatory strategies for in vitro diagnostic devices.

· Maintain accurate registration and license information, including approval scope, product/model/SKU coverage, legal manufacturer, manufacturing sites, license conditions, renewal dates, commitments, change-notification obligations, and supporting evidence.

· Prepare or support regulatory submissions and responses to authority questions and Country Regulatory Affairs requests; ensure responses are complete, consistent, traceable, and aligned with the approved regulatory strategy.

· Prepare, review, compile, and maintain regulatory submissions and technical documentation to support product registrations, clearances, approvals, and market access activities.

· Create, compile, quality-check, and maintain modular Global Dossiers that countries can use to prepare local submissions, using a consistent dossier structure and controlled source documentation.

· Prepare dossier bridging and clarification documentation that explains the relationship and traceability between applicable legacy Client technical documentation and Waters-issued documents, without overstating document ownership or equivalence.

· Perform dossier and submission readiness reviews, including document currency, approval status, consistency, translation needs, product applicability, confidentiality, and country acceptance requirements.

· Use established controls when sharing confidential or proprietary technical documentation; work with document owners…