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 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…