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

Initiate Local label Requests through Change Requests

Dashboards and Reporting for International Registrations, Labelling and Gap Assessments

Requirements :

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 :

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.

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 .

#LI-PHILIN

Skills Required

Continuous Improvement, Data Management, Power Bi, regulatory intelligence , Regulatory Requirements, conformity assessment