Regulatory Affairs Project Manager

SUMMARY DESCRIPTION * A San Francisco Bay Area based medical company is seeking a Regulatory Affairs Project Manager for their expanding organization. The RA Project Manager will work cross functional teams to secure approvals and clearances of PMA, 510(k), and OUS submissions. RESPONSIBILITIES * Create timelines and track deliverables to timelines to ensure that all submissions are submitted in a timely fashion * Compose, edit, and review regulatory documents to ensure that all 510(k) or PMA submissions are submitted effectively * Actively identify issues and implement appropriate plans for regulatory strategies to minimize risks. * Interface with global Regulatory authorities such as FDA and Notified bodies * Ensure that the project meets or exceed corporate goals on a consistent basis * Maintain exceptional knowledge of global regulations and procedures EXPERIENCE * Strong scientific background and at least 4+ years of experience in Regulatory Affairs in the medical device industry. BS degree in life science, advanced degree preferred. * Thorough understanding of global drug development regulations and guidelines * Exceptional interpersonal skills and effective task planning * Proven ability to successfully manage major submissions and critical projects to deadlines * Problem-solver capable of identifying risks and implementing risk mitigation strategies

To find out more about Real please visit www.realstaffing.com [1]

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[1] http://www.realstaffing.com