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Regulatory Administrator

Company:
Relevante
Location:
Long Island, Nova Scotia, Canada
Posted:
December 05, 2018

Description:

We have partnered with a large Manufacturing company in the New Island, NY area to provide them with a Regulatory Administrator.

Please review the below description and if you are interested please contact:

Vahidin Topcagic at vtopcagic@relevante.biz, 314-853-6670

Job Description:

Summary:

The Administrator of Regulatory Affairs is responsible for the technical writing aspects of medical device regulatory affairs product submissions for Client. in the United States, Canada, Europe, South America, Asia Pacific, the Middle East and Africa. The Administrator is also responsible for the activities related to the tracking of medical device regulatory affairs products submissions, request for information, and labeling status.

Essential Responsibilities: include the following:

Assemble documentation for new medical device regulatory filings

File amendments and update files as necessary

Create and maintain 510(k) medical device submission

Create and maintain European Technical Files

Create and maintain worldwide medical device product registrations

Communicate with manufacturers to obtain necessary information required for filings

Track medical device renewal requirements

File medical device renewals

Track status of medical device registrations and answer questions

Generate and provide Certificates of Foreign Goods upon request

Service as liaison with medical device distributors, consultants, and product managers regarding provision of standard information such as latex statements, TSE/BSE, DHP/PVC, and RoHSS information related to medical device products.

Education and/or Experience Required:

B.S. or B.A. degree in life sciences, (biology, chemistry, immunology, engineering, etc.)

A minimum of three years relevant experience in medical device regulatory affairs and compliance.

General knowledge of FDA, Canadian, and European Medical Device regulations required.

Excellent oral and written skills are required.