Regulatory Affairs Senior Specialist

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 and compliance with applicable regulations
* Knowledgeable about current US and international regulatory practices, procedures, and changes. Assesses impact of the changing regulatory environment to the project, and advises regulatory colleagues and project team members, as appropriate, regarding potential course(s) of action
* 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 5 years regulatory experience in a biotechnology, pharmaceutical, or medical device company
* Bachelors degree necessary, Masters degree in Regulatory Affairs preferred
* 510(k) submission experience necessary, PMA experience always a plus
* 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