Regulatory Operations Specialist

Laborie Medical Technologies Corp•Portsmouth, NH

36d

About The Position

As a key member of the Regulatory team, the Regulatory Operations Specialist will interact with Supply Chain, Quality, Sales, Customer Care and Manufacturing, ensuring that product approvals are properly maintained, and product re-registrations are properly managed.

Requirements

2+ years of industry experience.
AS degree in Science, Engineering, or other relevant discipline.
Must have the ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel.
Proficiency with MS Office and Adobe publishing.
Strong analytical skills and the ability to solve problems through analytical reasoning.

Nice To Haves

BS degree in Science, Engineering, or other relevant discipline.
Strong planning and organizational skills.

Responsibilities

Create and maintain data for import / export, inclusions as well as manufacturing implementations in SAP.
Publish submission documentation, maintain submission logs, and generate reports as necessary.
Process documents for notarization, legalization and apostille; maintain State and Regulatory Body License renewals as required.
Advise Regulatory staff of registration renewals and maintain distributor renewal log.