Regulatory Affairs Operations Specialist

The Regulatory Affairs Operations Specialist will manage international registrations, including uploading, verifying, and validating regulatory data, maintaining licensing information, and creating submission packages. Key responsibilities also involve initiating renewals and product change notices, and updating regulatory status in various systems. The role includes managing international and local labeling requests, monitoring their implementation, and ensuring timely label releases. Additionally, the specialist will be responsible for maintaining dashboards and reports for registrations, labeling, and gap assessments, as well as managing establishment registrations and device listings for global markets. This position requires 5+ years of experience in medical device regulatory affairs, strong data analytical skills, and expertise in Office 365 tools like Power BI and Automate.

Must Have

• Upload, verify, and validate data in RIM database
• Maintain Registration & Licensing Information
• Create Submission Packages for International Registrations
• Initiate Renewals with countries
• Initiate Product Change Notices
• Establish and maintain Dashboards on Product Change Notices
• Update PRAs (RIMSYS), NOR-D, and SAP on regulatory status
• Initiate Local label Requests through Change Requests
• Monitor label change requests through implementation
• Ensure timely completion of label release by R&D
• Publish label status to stakeholders
• Create Dashboards and Reporting for International Registrations, Labelling and Gap Assessments
• Manage Establishment Registrations & Device Listing for USA, Canada & EU
• Maintain repository of Declaration of Conformity, LTFs, 510(k)s, TD Documentations
• Maintain EUDAMED, GUDID and other Regulator Databases
• 5+ years professional experience in medical device regulatory affairs
• Excellent Data Analytical skills
• Expert user in Office 365 tools (Power BI, Automate)
• Strong knowledge and experience in international registrations
• Good Documentation Practices

Good to Have

• Experience with quality management, product development systems
• Research, outline, write, and edit content for regulatory requirements
• Gather information from subject-matter experts for submissions
• Work with leads to identify documentation repositories
• Research, create, and maintain information architecture templates
• Develop content in alternative media forms for maximum usability
• Bachelor's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent
• RAPS RAC certification
• Regulatory Requirements knowledge
• Document Auditing
• Data Management
• Administrative Support
• Product Registrations
• Product Labeling
• Strategy Implementation
• Stakeholder Management
• Regulatory Submission Documentation
• Conformity Assessment
• Regulatory Intelligence
• Continuous Improvement

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 PRAs (RIMSYS), NOR-D, and SAP system on regulatory status
• International and Local Labelling
• 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.

Requirements :

• Degree in engineering or a related discipline.
• 5+ 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 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

Preferred Education:

Bachelor's Degree / Vocational Education in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent

Preferred Experience:

5+ 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 company’s facilities.

Field roles are most effectively done outside of the company’s 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 won't 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 you’re 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.

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