Senior Regulatory Affairs Coordinator

Job Description
Summary
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Excellent opportunity to work for a global Med-Tech business
Great opportunity to be apart of a dynamic team working on exciting projects

About Our Client

My client is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care.

Job Description

Assists in preparing, auditing, editing, and publishing registration documentation.
Collects, stores, and maintains all RA documentation, including correspondence and approvals.
Main liaison for market clearance activities, interacting with sales and marketing organization for provision of RA documentation for business tenders
The First point of contact for customer inquiries and requests, triaging multiple requests per business urgency/criticality
Monitoring and updating regulatory trackers to assist projects workflow
Assists with notarization, legalization and apostille process for regulatory documentation.
Maintaining data on the RA database to ensure accuracy, updating registration data, as needed.
Following up with the international RA departments based in Europe, Middle East & Africa, Asia, Latin America for collection of impact assessments

The Successful Applicant

Bachelors or Associates Degree, preferred
Regulatory Data Management experience (ideally 3 years plus)
Represent Regulatory Affairs in multiple environments (i.e., Marketing, engineering, etc.) and work with all levels of management.
Read, analyze, and interpret regulatory literature and documents while effectively communicating information to peers and management while working independently with minimum supervision.
Define problems, collect data, establish facts, make decisions, solve practical problems