Regulatory Affairs Manager (Jacksonville)

This position is located in Knoxville, TN and relocation assistance is offered for the right candidate.

Develops, establishes and implements and practices activities required to produce regulatory clearence or approval for new and revised product lines to meet customer and regulatory requirments. Plans, coordinates, and directs all Regulatory Affaris programs and helps establish standards designed to ensure continuous production of products by performing the following duties:

System and enviromental programs are established, implemented and maintained in accordance with applicable standards

Completetion of RA tasks set the pace of product sterility validations and release to market

Implementing internal and customer product release requirments ensuring product quality requirments are realized

Designing measurement systems to meet specifications, managing raw material suppliers (specifications, regulatory requirments and quality systems requirements)

Creating controlled documents for processes, inspections, and test

Responsible for enviromental controls of the Clean Room are carried out to specifications

Ensures continuous compliance with FDA and ISO standards, and other regulations, as applicable

Train workforce as required in various Regulatory procdures


Bachelor’s Degree

5 years experience in the Medical Device industry

Experience with 510k filings

Salary is $80,000 to $100,000

Address: : Jacksonville, FL 32202 (map)

Date Posted: : 07/15/14

Job Type: : Full-time

Description: :

Ad author : Ad Partner

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 August 8, 2014 ·  
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