America's Job ExchangeAJE

Responsibilities:

ýýý Develop and execute regulatory strategies for new and modified products.

ýýý Prepare 510K submissions to obtain and maintain domestic regulatory clearances.

ýýý Provide technical and regulatory guidance to new product development and product management teams.

ýýý Develop and maintain positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy, regulatory pathway development, testing requirements and follow up of submissions under review.

ýýý Review device labeling and promotional material for compliance with applicable regulations.B.S. in scientific discipline

ýýý Minimum of 5 years of Regulatory Affairs medical device industry experience.

ýýý Demonstrated success in the management of device 510k submissions is required; internationa and/or PMA experience a plus.

Job Benefits