Regulatory Operations Specialist

Laborie Medical Technologies Corp•Portsmouth, NH

About The Position

We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you. We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion. Who We’re Looking For: 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. About the Role: 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 a postille; maintain State and Regulatory Body License renewals as required. Advise Regulatory staff of registration renewals and maintain distributor renewal log.

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 a postille; maintain State and Regulatory Body License renewals as required.
Advise Regulatory staff of registration renewals and maintain distributor renewal log.