Senior Regulatory Affairs Associate


Pleasanton, CA

What you'll be doing

Develop domestic or international strategies for regulatory approval of company products. Represent RA on cross-functional product development and manufacturing support teams. Guide teams to provide content for US or international submissions, participate in design reviews as needed. Coordinate, compile and submit U.S or international regulatory submissions, including filing or creation of PMAs, IDEs, premarket notifications, supplements, change notifications and other country-specific product registrations. Review product and manufacturing change for compliance with applicable regulation and indication for use; assess change and make recommendations to initiators for required justification or validation documentation. Prepare RA change assessments to support recommended submission decision. Review and approve device labeling and advertising material content for compliance with global submissions and applicable regulations; analyze and recommend appropriate changes. Communicate with and maintain productive, constructive relationships with companies external customers as required US FDA, health Canada, regulatory representatives and notified-bodies. Review product complaint reports assessed by customer services for reporting determination. Participate in department or company systems development initiatives. May participate in training and mentoring of staff. Perform other duties and projects as assigned by manager, regulatory affairs.

What your background should be

Four to eight years experience in medical device industry, with at least four years of experience involving regulatory submissions for class II or III medical devices. Must be familiar with relevant US or international regulatory requirements for medical devices including quality systems standards and clinical investigations. Experience working directly with FDA, notified bodies or international health authorities necessary. Ability to plan, prioritize, balance, schedule and mange simultaneous projects. Excellent oral and written communication skills. Team player with excellent interpersonal skills. Experience with word processing, spreadsheet and presentation graphic software packages is required.

Required Schooling / Training

BA or BS degree in life sciences or engineering, or an acceptable alternative, is required.

Who is the client company

This is a United States-based company that develops, manufactures and markets proprietary medical devices used for mechanical circulatory support for the treatment of heart-failure patients worldwide.
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