Regulatory Affairs Operations Specialist

Job Title

Regulatory Affairs Operations 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 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 :

Bachelors 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 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 :

IC

Key Skills

Athletics,Corporate Banking,Dreamweaver,Facilities,IT Support

Employment Type : Full-Time

Experience : years

Vacancy : 1