Description
Along with senior management team, the regulatory affairs director sets direction for clinical studies and regulatory filings, defines objectives and outputs; and determines the cost, schedule, priority to accomplish objectives. Responsible for establishing and maintaining Budget for Regulatory Submissions, May partner with Clinical Research teams to providing guidance and clarification as needed.Interprets results of phase 1- 4 investigations in preparation for regulatory submissions and / or publications. Responsible for the management of US based Regulatory staff.
Set direction for Regulatory Affairs. Writes and / or reviews of all US and Canadian regulatory submissions. Writes, amends and releases all technical files and design dossiers for medical devices and solutions for North America.
Participates in FDA audits and correspondences. For Regulatory needs, acts as the primary liaison with FDA.
* Act as the primary interface with Food and Drug Administration on regulatory issues and submissions.
* Recommends regulatory plan strategies and oversees or leads regulatory submissions
* Effectively leads and manages US based regulatory affairs staff
* Manages US based budget for regulatory submissions
* Partners effectively with global Marketing, R&D, and Quality organization to ensure alignment of regulatory goals and objectives for full spectrum of product development lifecycle.
* Partners effectively with Clinical affairs staff
* Participates in FDA audits and provides strong leadership with audits, 3rd party interactions
* Responsible for review and approval of all regulatory and controlled documentation
* Partners with Regulatory Staff OUS to ensure functional alignment and excellence in process.
Education and Experience Required
* Bachelors Degree required. Masters degree highly desirable
* 12+ years regulatory experience
* 6 + years clinical experience
* Supervisory experience and leadership skills
To find out more about Real please visit www.realstaffing.com