Sr Regulatory Operation Specialist

• 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.

• 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

Bachelor's 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

RAPS RAC certification

• 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

Compensation & benefits
Doing meaningful work should come with fair, transparent rewards. The base salary range for this role is €[Min]–€[Max]. We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you'll have in this role, alongside internal equity and local market considerations.
This role is eligible for [bonus/incentive], with your rewards linked to [KPIs/company results]. We’ll share the full approach with you during the interview process, so you can make a clear, informed decision. Benefits include [key benefits].
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.
About Philips
Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and 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.

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