Regulatory Operations Specialist II

ECI is hiring a Regulatory Operations Specialist II to maintain regulatory information, registration records, and documentation across global markets. The role supports regulatory submissions, data quality and governance, compliance tracking, and regulatory process improvement for medical device activities.

Responsibilities

• Maintain and manage 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

Preferred

• Bachelor's Degree in Engineering, Science or Regulatory affairs is preferred
• Experience with Regulatory Information Management (RIM) platforms preferred
• Engineering Degree
• Science Degree
• Regulatory Affairs Degree
• Regulatory Information Management Platforms

Company

• Life sciences quality, regulatory, engineering, and testing services
• Marlborough, Massachusetts, USA
• https://eci-rx.com/
• Founded in 2012
• 201-500 employees

Qualifications

• 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
• Experience supporting regulatory submissions and product registration activities in multiple global markets
• Strong data management, documentation, and organizational skills with exceptional attention to detail
• Proficiency with Microsoft SharePoint, Excel, Power BI, and document management systems
• Ability to manage large volumes of regulatory information and maintain data accuracy across multiple systems
• Excellent communication and cross-functional collaboration skills
• Bachelor's Degree in Engineering, Science or Regulatory affairs is preferred
• Experience with Regulatory Information Management (RIM) platforms preferred
• Minimum of 3-5 years experience in Regulatory Affairs, Regulatory Operations, Regulatory Information Management, or Quality Systems within the medical device industry.

Required skills

• FDA Regulations, International Registration Processes, Medical Device Regulations, Microsoft Excel, Microsoft SharePoint, Power BI, Product Registration, Regulatory Affairs, Regulatory Information Management (RIM), Regulatory Submissions, UDI/GUDID Requirements

Preferred skills

• (1), (3), *2024, 2021, 2022, 2026-02-17, 60, AI Tools, Chief Financial Officer, Chief Operating Officer, Company data provided by, Costa Rica to Host Latin America's Leading MedTech Forum, Customize Your Resume, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, Engineering and Development, Enhanced Compliance Inc., Growth Stage, H1B Sponsorship, Leadership Team, Legal and Compliance, Marlborough, Massachusetts, USA, Maximize your interview chances, Michael Boyer, PR Newswire, Recent News, Represents job field similar to this job, Shital Patel, Trends of Total Sponsorships, https://eci-rx.com

Experience

• 3-5 years