About this role
Job title: Spec RA GSO
Job Summary
Job Description
- 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;
- 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;
- Train new hires when necessary
- Participate in the new hire on-boarding meetings and monthly