Specialist, Regulatory Digitization

Position Overview

The Specialist Regulatory Digitization will support the digitization and continuous improvement of regulatory information management processes, systems, and data. This role will help maintain and enhance regulatory data quality, support RIMS-related process execution, contribute to data migration and documentation activities, and work closely with cross-functional stakeholders and vendors to strengthen regulatory digital capabilities.

The position requires a blend of regulatory operations understanding, system/data capability, process discipline, and stakeholder collaboration. The successful candidate will help ensure that regulatory data, workflows, and supporting systems are structured, compliant, and scalable to meet business needs.

Expected Responsibilities

Regulatory Data and RIMS Support

• Develop a working understanding of regulatory data requirements for each country maintained in the Regulatory Information Management System (RIMS).
• Review and audit existing regulatory data to identify quality gaps, inconsistencies, and opportunities for improvement.
• Prepare and support regulatory data setup for onboarding new countries or markets into the system.
• Support certificate and document maintenance activities within RIMS to improve accuracy, traceability, and efficiency.
• Generate, review, and interpret RIMS reports to support operational and business needs.
  
  

System Administration

• Understand and support system parameters and user role management within the regulatory digital environment.
• Build knowledge of the underlying technology, including system strengths, limitations, and practical application in regulatory operations.
• Develop awareness of related systems and data sources such as QMS, content/document systems, and enterprise data platforms that support regulatory processes.
• Contribute to evaluation and continuous validation of current RIMS implementation against business needs and available market capabilities.
  
  

Process Documentation

• Observe and support execution of regulatory processes to ensure alignment with applicable QMS procedures.
• Prepare documentation required for data migration and validation activities.
• Assist in updating existing QMS procedures and supporting the introduction of new processes where needed.
  
  

System Integration

• Support discussions related to system integration by understanding the technologies involved and their implications for regulatory data flow.
• Understand the business value of regulatory data and help influence stakeholders toward effective data and system practices.
• Collaborate with teams such as Regulatory Affairs, Quality Assurance, IT, Testing, and Supply Chain to support RIMS-related initiatives.
• Build strong working relationships with Regulatory Affairs team members and other internal stakeholders to enable adoption and continuous improvement.
  
  

Vendor Coordination

• Develop understanding of vendor contracts, scope, and support model.
• Participate in vendor meetings and working sessions at different levels.
• Monitor vendor actions, follow up on deliverables, and communicate relevant observations back to internal teams.
  
  

Skills Required


Technical / Functional Skills

• Understanding of regulatory operations, regulatory documentation, or regulatory information management processes.
• Ability to work with structured data, review records, identify gaps, and improve data quality.
• Familiarity with RIMS platforms or other regulated business systems is preferred.
• Ability to interpret system workflows, reports, user roles, and configuration concepts.
• Working knowledge of QMS-controlled environments and documentation practices.
• Exposure to data migration, validation documentation, or system implementation activities is desirable.
• Awareness of enterprise systems and data interfaces such as document management, ERP, or analytics platforms is an advantage.
  
  

Soft Skills

• Strong analytical and problem-solving capability.
• Good attention to detail and ability to work accurately in regulated environments.
• Ability to work independently while also collaborating across multiple functions.
• Clear written and verbal communication skills.
• Strong stakeholder engagement and relationship-building capability.
• Ability to manage multiple priorities and adapt in a changing digital environment.
  
  

Preferred Experience

• Experience in Regulatory Affairs, regulatory operations, quality systems, or regulated digital/process support roles.
• Experience working in a medical device, pharmaceutical, or other regulated industry environment.
• Exposure to RIMS, QMS, validation documentation, or digital transformation initiatives.
• Experience coordinating with software/system vendors and cross-functional business teams.
  
  

Joining us is more than saying yes to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!