Job Details

Regulatory Affairs Associate

Company name

BARD Peripheral Vascular.

Organization Type

In-House

Job Type

Non-practicing Attorney

Date Last Verified

Aug 07,2018

Posted on

Jul 26,2018

Years of Experience

Max 1 yrs required

Location

Tempe, AZ
Practice Area
Intellectual Property >> Intellectual Property - Patent >> Intellectual Property - Patent - Life Sciences >> Biology
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Regulatory Affairs Associate The candidate implements BDPI domestic and international regulatory affairs procedures. Acts as a liaison to Corporate Law Department, providing requested information. 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. Excellent problem solving and analytical skills is essential. Good written and oral communication skills is essential. Must have a Bachelors Degree in Law, Engineering, Biology or one of the Life Sciences. Must have 0-1 year of experience in a regulatory or documentation environment or related field. Knowledge of federal medical device regulations is essential.

Additional info

Job ID 2018-11764

Company info

Hiring Coordinator
BARD Peripheral Vascular.
1415 West 3rd Street
Tempe, AZ 85281