Regulatory Affairs Specialist GSO

Job Summary

Job Description

1. Review and document labeling designed by Medline designers for products of commodity, medical device, drug /or cosmetics

• Review Medline branded labels to ensure that all information on the labeling is in accordance with Medline internal procedures, relevant federal laws and regulations;
• Review the designed labeling against the requests and mock-ups provided by product manager (PM);
• Coordinate with product managers (PM), quality assurance (QA), designers and other regulatory affairs (RA) co-workers on problems and conflicts related to Medline branded labels;
• Archive approved labels as per Medline internal procedures and instructions;

2. Labeling related quality issue solving and project supporting

• Communicate with suppliers for effective labeling implementation
• Conduct investigation and corrective action on detected labeling problem (CAPA), lead the supplier labeling related problem solving and improvement (SCAR)
• Participate and work closely with project leader for labeling related project plan setup and implementation
• Provide professional advice during risk assessment and problem-solving based on experience and related regulations/requirements;

3. Train new hires when necessary

• Participate in the new hire on-boarding meetings and monthly review, give advice if necessary;
• Train the new hire on the labeling review process and requirements;
• Guide new hire to practice by real labeling review jobs;
• Provide feedback to manager on the new hire.

4. Collect, update and maintain the regulatory data (optional)

• Collect the UDI data and FDA product registration data from different Medline systems;
• Update and maintain the regulatory data in Medline and GUDID system as required.

5. Post market and vendor related affairs (optional)

• Adverse event searching and analysis for CE-marked devices;
• Initiate the certificate of conformity and Declaration of Conformity per request.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging pagehere.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.