Regulatory Affairs Spec 4

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

Job Responsibilities:(Primary Duties, Roles, and/or Authorities)

·       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 and Legal or Quality as needed to determine an appropriate submission format or controlled disclosure approach.

·       Monitor project milestones and regulatory deliverables; communicate status, decisions,

·       Support compliance with global IVD regulatory requirements, including FDA regulations, EU IVDR (EU) 2017/746, UK regulations, Health Canada requirements, and other international regulatory frameworks.

·       Prepare and maintain technical documentation, design dossiers, product registrations, declarations of conformity, and supporting regulatory records.

·       Conduct regulatory impact assessments for product, manufacturing, supplier, software, labeling, design, and process changes.

·       Apply change management principles to assess, document, communicate, and implement regulatory strategies for design, manufacturing, supplier, labeling, software, clinical, and post-market changes.

·       Partner with Research & Development, Clinical Affairs, Quality Assurance, Manufacturing, Medical Affairs, and Marketing teams to ensure regulatory requirements are incorporated throughout the product lifecycle.

·       Review and approve product labeling, instructions for use (IFUs), promotional materials, and other product-related documentation for regulatory compliance.

·       Support interactions with regulatory authorities, notified bodies, competent authorities, and other regulatory agencies, including submission preparation and responses to questions, deficiencies, and audit findings.

·       Monitor and interpret new and evolving regulatory requirements, standards, guidance documents, enforcement trends, and health authority expectations relevant to IVD products.

·       Translate regulatory intelligence into actionable impact assessments, recommendations, and implementation plans for affected products, submissions, procedures, and quality-system processes.

·       Support product lifecycle management activities, including change control assessments, market expansions, field actions, vigilance reporting, and regulatory maintenance activities.

·       Provide regulatory support for analytical and clinical performance studies, product claims development, and evidence generation activities.

·       Contribute to regulatory intelligence initiatives and communicate regulatory impacts to internal stakeholders.

·       Support internal and external audits and inspections.

·       Develop and maintain regulatory procedures, work instructions, and related quality system documentation.

·       Provide regulatory training and guidance to cross-functional stakeholders.

·       Perform other Regulatory Affairs duties and assignments as required.

Education and Experience:

·       Bachelor's degree in Biological Sciences, Biomedical Engineering, Medical Technology, Chemistry, Engineering, Clinical Laboratory Sciences, or a related scientific discipline.

·       Minimum 5 years of Regulatory Affairs experience in the medical device, in vitro diagnostic, biotechnology, or related regulated industry.

·       Experience supporting regulatory submissions and registrations for in vitro diagnostic devices.

·       Experience with one or more major regulatory frameworks such as FDA 510(k), De Novo, PMA, EU IVDR, UKCA, Health Canada, PMDA, NMPA, or other international regulatory pathways.

·       Experience supporting regulatory assessments related to product development, sustaining engineering, labeling, software, manufacturing, or clinical studies.

·       Experience performing regulatory intelligence monitoring, interpretation, impact assessment, and communication of new or revised regulations, standards, guidance documents, and health authority expectations.

·       Experience supporting change management and regulatory change control activities, including assessment of design, manufacturing, supplier, software, labeling, process, and post-market changes.

·       Regulatory Affairs Certification (RAC) preferred.

·       Experience working with flow cytometry, companion diagnostics, or other IVD technologies is desirable.

Knowledge and Skills:

·       Strong knowledge of global medical device and IVD regulatory requirements and lifecycle management, technical documentation, and post-approval license maintenance.

·       Ability to interpret country requirements, distinguish global core documents from local requirements, and translate regulatory requirements into clear deliverables and actions. 

·       Working knowledge of FDA Quality System Regulation (QSR), ISO 13485, EU IVDR, and applicable international standards and guidance documents.

·       Understanding of analytical and clinical performance requirements for IVD devices.

·       Experience preparing technical documentation, regulatory submissions, and responses to regulatory authority questions.

·       Advanced technical writing and document-review skills, with strong attention to consistency, traceability, version control, product applicability, and audit readiness.

·       Ability to independently assess regulatory risks and propose compliant business solutions.

·       Strong project-management capability, including planning, prioritization, issue resolution, stakeholder coordination, status reporting, and management of multiple concurrent country submissions..

·       Demonstrated ability to lead regulatory activities within cross-functional teams.

·       Excellent analytical and problem-solving capabilities.

·       Effective written and verbal communication skills and the ability to explain complex regulatory topics to technical and non-technical stakeholders. 

·       Ability to influence without direct authority, work effectively across cultures and time zones, and escalate issues with clear options and recommendations. 

·       Proficiency with Microsoft Office applications and regulatory information management systems.

·       Ability to manage multiple projects simultaneously while meeting deadlines.

·       Fluency in English required; additional language capability is beneficial.

Physical Demands: (if applicable)

Primarily desk-based work. Ability to use a computer and participate in virtual meetings for extended periods. Occasional travel may be required based on business and project needs. 

Work Environment: (if applicable)

Hybrid office environment/ Remote as approved. Regular collaboration across global time zones is expected.