PR:$32.50/hr
Job Description: Job Description Summary
Provide regulatory certificates globally which includes tracking status and attention to detail. Candidate will have a 4-year degree in science or engineering and be proficient in Microsoft Office applications.
Job involves interacting with regulatory affairs personnel from 80+ countries who are registering or re-registering medical devices or drugs locally. Certificates may need to be notarized, apostilled, or authenticated via the Washington Consulate Service. Individual will become a notary to carry out job duties.
The Regulatory Affairs Coordinator will have responsibility for providing support to marketed products for the Health Care Business Group.
Primary Responsibilities include but are not limited to the following:
1. Support international submissions
a. Respond to requests from subsidiaries for certificates and declarations of conformity
b. Obtain authentication for documents through the apostille process
2. Assist with imports
Minimum Requirements:
•Bachelor’s degree or higher in a Science discipline from an accredited institution
Preferred:
•Bachelor's degree or higher in Biology, Chemistry, or engineering, or related disciplined from an accredited institution
•Detailed oriented, ability to navigate a matrix environment
•Experience working on a cross-functional team
•Microsoft Office proficient
•Minimum of two (2) years regulatory experience with drug and/or medical device products.
Would like it if candidate is currently a Notary; if not, they will have them go through the process to become one.
Candidate will be trained on document control system.
Regarding GTS, this is the primary function:
Use SAP Global Trade Services (GTS) to manage export license data to manage international trade orders for product export; automatically sending approved products for fulfillment while blocking products from shipment that are not licensed/registered to the targeted market.
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.” •
Last updated on Nov 17, 2023