Global Regulatory Operations Specialist II

Enhanced Compliance Inc.; Parsippany-Troy Hills (NJ); Presencial; USD 90 000 - 120 000; Tempo integral

Resumo da oferta

Enhanced Compliance Inc. seeks a Regulatory Affairs Data Specialist to maintain regulatory information across RIM systems, SharePoint, and global databases.

You will collect, organize, verify, and enter data to support registrations, renewals, and market maintenance activities, while tracking commitments and ensuring data quality. Responsibilities include maintaining registration trackers, coordinating documentation from cross-functional teams, and supporting submissions for FDA registrations

Qualificações

• Bachelor’s Degree in Engineering, Science or Regulatory affairs is preferred.
• Minimum of 3-5 years experience in Regulatory Affairs, Regulatory Operations, Regulatory Information Management, or Quality Systems within the medical device industry.
• Experience maintaining regulatory databases, SharePoint sites, RIM systems, or product registration tracking tools.
• Working knowledge of FDA regulations, product registrations, UDI/GUDID requirements, and international registration processes.
• Excellent communication and cross-functional collaboration skills.

Responsabilidades

• Maintain regulatory information within Regulatory Information Management (RIM) systems, SharePoint repositories, and other regulatory databases.
• Collect, organize, verify, and enter regulatory information required to support product registrations, submissions, renewals, and market maintenance activities.
• Maintain registration status trackers and dashboards to ensure accurate visibility of global product registrations and regulatory commitments.
• Identify and document where products are registered globally, including registration numbers, approval dates, renewal requirements, and associated regulatory obligations.
• Support regulatory data migration, cleansing, reconciliation, and governance initiatives to improve data quality and consistency.
• Monitor and track regulatory submissions, approvals, renewals, licenses, and registrations across global markets.
• Maintain UDI, GUDID, EUDAMED, and country-specific registration records as applicable.
• Support preparation and compilation of documentation required for FDA registrations, establishment registrations, product listings, and international market registrations.
• Coordinate collection of regulatory documentation from cross-functional stakeholders and ensure documents are appropriately archived and version controlled.
• Create, maintain, and update regulatory trackers, metrics, reports, and compliance dashboards.
• Support management of regulatory commitments, post-approval requirements, registration renewals, and change notifications.
• Review and maintain regulatory documentation repositories, ensuring records are inspection-ready and aligned with company document control practices.
• Assist with product registration and listing activities for global markets, including the U.S., EU, Canada, and other international regions.
• Support maintenance of Technical Documentation, Design Dossiers, Technical Files, and submission archives.
• Provide administrative and operational support for regulatory submissions including document formatting, publishing, compilation, and submission logistics.
• Collaborate with Regulatory Affairs personnel to support market access strategies and lifecycle management activities.
• Support implementation and continuous improvement of regulatory processes, workflows, systems, and data management practices.

Conhecimentos

Regulatory data management

SharePoint knowledge

Data analysis

FDA regulations knowledge

Cross-functional collaboration

Formação académica

Bachelor’s degree in Engineering, Science or Regulatory affairs

Ferramentas

SharePoint

Power BI

Excel

Document management systems

Descrição da oferta de emprego

Enhanced Compliance Inc. seeks a Regulatory Affairs Data Specialist to maintain regulatory information across RIM systems, SharePoint, and global databases.

You will collect, organize, verify, and enter data to support registrations, renewals, and market maintenance activities, while tracking commitments and ensuring data quality. Responsibilities include maintaining registration trackers, coordinating documentation from cross-functional teams, and supporting submissions for FDA registrations