Sr Regulatory Operation Specialist

Job Summary

Job Title Sr Regulatory Operation Specialist

Job Responsibilities

International Registrations

• Upload, Verify, and Validate the data with new Regulatory Information to the RIM database
• Maintain Registration Licensing Information
• Create Submission Packages for International Registrations
• Initiate Renewals with the countries.
• Initiate Product Change Notices per input from BU Project RA Specialist
• Establish and Maintenance of Dashboards on Product Change Notices
• Update (RIMSYS), PCN tracker Master sheet, Maintaining AOP list
• Initiate Local label Requests through Change Requests
• Monitor the status of the Label Change requests through Implementation
• Ensure timely completion of label release happens by RD (every 6-8 weeks.)
• Publish the status to the stakeholders on weekly/monthly
• Maintenance Reporting Dashboards and Reporting for International Registrations, Labelling and Gap Assessments
• Establishment Registrations Device Listing for the USA, Canada EU.
• Maintain repository of report Declaration of Conformity, LTFs, 510(k)s and TD Documentations
• Maintain EUDAMED, GUDID and other Regulator Databases as required for the region using ReedTech Software.

Regulatory Requirements

• Gather information from subject-matter experts and develop, organize, and write documentation for submissions
• Work with development and support leads to identify documentation repositories, revise and edit, and determining best solutions for data compilation and centralized storage
• Research, create, and maintain information architecture templates that adhere to organizational and legal standards and allow for easy data migration
• Develop content in alternative media forms for maximum usability, with consistent voice across all documentation

Skills

• Assists in implementing comprehensive regulatory strategies by collaborating with regulatory and cross-functional subject matter experts (SMEs) to ensure alignment with company objectives and compliance with relevant regulations for limited scope typically smaller and less complex projects.
• Works under general supervision within established processes and operational policies, exercising independent judgment to ensure adherence to guidelines while achieving objectives effectively.
• Demonstrates basic understanding of regulator's role in the Quality System with basic awareness of product lines, disease states, and customers, possessing general knowledge of business developed through education or past experience.
• Applies analytical skills to resolve fewer complex requests efficiently, exercising judgment within defined procedures/practices to determine appropriate action.
• Fosters productive internal and external working relationships to resolve mutual problems by conveying information, contributing to streamlined operations and improved outcomes, primarily communicating with internal contacts within the immediate group.
• Collaborates with central and regional Regulatory Affairs teams to support establishment registration and listing, and UDI/Global Trade Identification Number (GTIN) related activities, maintaining processes for regulatory filings/ licenses and developing technical contribution.
• Supporting regulatory submissions, ensuring alignment with regulatory requirements and standards.
• Works within standardized procedures and practices to achieve objectives and meet deadlines, making decisions that have limited impact on own work team and minimal impact on business.
• Supports the coordination and preparation of regulatory submissions for product/solution licensing, ensuring accuracy and completeness to expedite approval processes efficiently, managing files for device updates and related control processes
• Keeps abreast of regulatory procedures and changes, participates in process improvement activities related to internal regulatory processes, as well as evolving Regulatory Agency changes.

Education Experience

• Bachelors Degree / Vocational Education in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent
• 10 years of professional experience in medical device regulatory affairs

Certification

• RAPS RAC certification

Preferred Skills

• Regulatory Requirements
• Document Auditing
• Data Management
• Administrative Support
• Product Registrations
• Product Labeling
• Strategy Implementation
• Stakeholder Management
• Regulatory Submission Documentation

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