2205 - 28875 International Product Registration Coordinator

DeRoyal is an Equal Opportunity/Affirmative Action employer. Interviewing and hiring practices at DeRoyal do not discriminate on the basis of race, color, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, genetic information, veteran status or any other category protected by law.

International Product Registration Coordinator

DeRoyal, delivering high quality medical products and innovative healthcare services, is actively searching for an International Product Registration Coordinator to join our corporate International team in Powell, TN. The ideal candidate will be responsible for Ensures that all project requests concerning international accounts are dealt with in an efficient and accurate manner.

Some responsibilities include:

Coordinate Regulatory Request between internal teams and external resources for in country registration by communicating guidelines and deadlines clearly, effectively, and consistently.

Partner with internal teams, including Sales, Marketing, Engineering, Supply Chain and Quality and Regulatory to build project Technical Files or Dossiers for Regulatory Compliance.

Notify team of changes to products and product offerings, review to determine how these changes may affect each market.

Create marketing materials, regionally specific, to assist with promotions of products.

Assist with sourcing of products to be used for international sales.

Bachelor’s degree and/or minimum 5 years relevant experience required. Knowledgeable with all applicable sections of the 21 CFR, 510(k) submissions, and MDR reporting and other domestic and international regulatory issues is requested but not required.

Ability to use ten-key, fax machine, office copier and computer required. Experience using Microsoft Word, Excel and PowerPoint required.