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 InformationCreate Submission Packages for International RegistrationsInitiate Renewals with the countries.Initiate Product Change Notices per input from BU Project RA SpecialistEstablish and Maintenance of Dashboards on Product Change NoticesUpdate PRAs (RIMSYS) NOR-D and SAP system on regulatory statusInternational and Local LabellingInitiate Local label Requests through Change Requests
Monitor the status of the Label Change requests through ImplementationEnsure timely completion of label release happens by R&D (every 6-8 weeks.)Publish the status to the stakeholders on weekly / monthlyMaintenance & ReportingDashboards 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 DocumentationsMaintain EUDAMED GUDID and other Regulator Databases as required for the region.Requirements :
Degree in engineering or a related discipline.10 years of professional experience in medical device regulatory affairsExcellent Data Analytical skills and expert user in Office 365 tools including Power BI and Automate etc. .Strong proven knowledge and experience international registrationsGood 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 Regulatory requirementsGather information from subject-matter experts and develop organize and write documentation for submissionsWork with development and support leads to identify documentation repositories revise and edit and determining best solutions for data compilation and centralized storageResearch create and maintain information architecture templates that adhere to organizational and legal standards and allow for easy data migrationDevelop content in alternative media forms for maximum usability with consistent voice across all documentationSkills-
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 regulators 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 processesKeeps abreast of regulatory procedures and changes participates in process improvement activities related to internal regulatory processes as well as evolving Regulatory Agency changes.Preferred Education :
Bachelors Degree / Vocational Education in Biomedical Engineering Business Administration Health Sciences Pharmaceutical Law or equivalent
Preferred Experience :
10 years of professional experience in medical device regulatory affairs
Preferred 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
Conformity Assessment
Regulatory Intelligence
Continuous Improvement
How we work together
We believe that we are better together than apart. For our office-based teams this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the companys facilities.
Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.
Indicate if this role is an office / field / onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters and we wont stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
If youre interested in this role and have many but not all of the experiences needed we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.
#LI-PHILIN
Required Experience :
Senior IC
Key Skills
Athletics,Corporate Banking,Dreamweaver,Facilities,IT Support
Employment Type : Full-Time
Experience : years
Vacancy : 1
