Sr Regulatory Operation Specialist

Job Title Sr Regulatory Operation Specialist Job Description 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 R&D (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. Requirements : • Degree in engineering or a related discipline. • 7-10 years of professional experience in medical device regulatory affairs • Excellent Data Analytical skills and expert user in Office 365 tools including Power BI and Automate etc. • Strong proven knowledge and experience international registrations • Good Documentation Practices and Independent to drive initiatives to improve the Way of Working. • First time right attitude. • Experience with systems for quality management, product development, and follow-up of procedures is • an advantage. • Research, outline, write, and edit content, working closely with various departments to understand • AI White belt Ninja certification 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 Skill s- • 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