Description
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