Senior Specialist in Regulatory Affairs

Primary Responsibilities:

* Coordinates and prepares (i.e., plans, writes, and reviews) timely submissions, including interfacing with other departments to obtain the necessary components and reports in accordance with regulatory agencies' guidelines
* Reviews submission-related documents from clinical, pre-clinical, research, development and manufacturing to ensure consistency with regulatory submissions with applicable regulations
* Knowledgeable about current US and international regulatory practices, procedures, and changes.
* Represents Regulatory Affairs on project teams within defined projects
* Maintains regulatory filings or records, including archive of submissions and FDA correspondences files
* Initiates development of regulatory strategies in conjunction with senior RA personnel

Qualifications/Requirements/Skills:

* Minimum of 3 years regulatory affairs experience
* Bachelors degree necessary, Masters degree in Regulatory Affairs preferred
* 510(k), PMA or International Submissions experience
* Must be able to work in a fast paced environment with demonstrated ability to effectively manage multiple competing tasks and demands
* Ability to work independently, take initiative and complete tasks to deadlines
* Demonstrated communication skills (interpersonal, written, verbal, listening)
* Demonstrated time management (timelines, schedules, task prioritization) and leadership skills
To find out more about Real please visit www.realstaffing.com