RESPONSIBILITIES

1. Review and document labeling designed by Medline designers for products of commodity, medical device, drug /or cosmetics
61 Review Medline branded labels to ensure that all information on the labeling is in accordance with Medline internal procedures, relevant federal laws and regulations;
61 Review the designed labeling against the requests and mock-ups provided by product manager (PM);
61 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;
61 Archive approved labels as per Medline internal procedures and instructions;
61 Initiate the simple labeling change request per the requirements of PM or QA
2. Support labeling-related projects
61 Participate in project related meetings and project plan setup;
61 Work with project members to implement the plan;
61 Provide professional advices during risk assessment and problem-solving based on experience and related regulations/requirements;
3. Train new hires when necessary
61 Participate in the new hire on-boarding meetings and monthly review, give advice if necessary;
61 Train the new hire on the labeling review process and requirements;
61 Guide new hire to practice by real labeling review jobs;
61 Provide feedbacks to manager on the new hire.
4. Collect, update and maintain the regulatory data (optional)
61 Collect the UDI data and FDA product registration data from different Medline systems;
61 Update and maintain the regulatory data in Medline and GUDID system as required.
5. Post market and vendor related affairs (optional)
61 Adverse event searching and analysis for CE-marked devices;
61 Initiate the certificate of conformity and Declaration of Conformity per request.


Qualification

61 Education level: Bachelor degree in science, engineering or healthcare related field;
61 Working experience: At least 3-year working experience in quality or medical device related field;
61 Specific knowledge: Laws and regulations related to medical device labeling and registration/listing;
61 Certifications: CET 6 (or equivalent) or above;
61 Language: Good at verbal and written English.