Job Details

Regulatory Affairs Associate

Company name

BARD Peripheral Vascular.

Organization Type

In-House

Job Type

Attorney

Years of Experience

Max 1 yrs required

Location

Tempe, AZ

Date Last Verified

Dec 09,2017

Posted on

Dec 07,2017
Practice Area
Intellectual Property >> Intellectual Property - Litigation >> Intellectual Property - Litigation - Life Sciences >> Biology
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Regulatory Affairs Associate Essential Job Functions: Supports senior Regulatory personnel prepare new product marketing submission for the FDA (510k, PMA). Maintains all Regulatory Affairs documentation. Assists as a Regulatory representative on New Product Development teams. Supports all international Regulatory requests. Sends out notifications of change to the Notified Body as required. Supports divisional and corporate litigation requests as needed. Assist in the preparation of division procedures to ensure compliance with Regulatory and Corporate requirements. Performs on special projects as required.

Qualification and Experience

The candidate should have a Bachelors Degree in Law, Engineering, Biology or one of the Life Sciences. Should have 0-1 year experience in a regulatory or documentation environment or related field. Ability to review, collate and summarize scientific and technical data. Ability to handle master documents, drawings, and specifications with a high degree of confidentiality. Excellent problem solving and analytical skills. Good written and oral communication skills. Knowledge of federal medical device regulations.

Additional info

Job ID : 2017-10927

Company info

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