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!