Description
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