Responsibilities:
§ Regulatory Affairs support of submissions and on going regulatory compliance for product development process
§ Under minimal supervision, act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review
§ Assist with developing and implementing regulatory strategies for new and modified medical devices
§ Act as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle
§ Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation
§ Review device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes
§ Review and signs-off on product and manufacturing changes for compliance with applicable regulations
§ Support and maintain Quality initiatives in accordance with BSC Quality Policy
§ Continuously assess ways to improve Quality
Requirements:
§ Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
§ Submissions experience a “must-have”, IND, NDA, PMA, etc.
§ 2 – 4 years Regulatory Affairs experience, medical industry experience preferred
§ Working knowledge of FDA and international regulations
§ General understanding of product development process and design control
§ General understanding of regulations applicable to the conduct of clinical trials
§ Ability to manage several projects
§ Proficiency with Microsoft Office
§ Effective research and analytical skills
§ Effective written and oral communication, technical writing and editing skills
§ Ability to work independently with minimal supervision
If you believe you are qualified for this position and you are interested in learning more, please email your CV/Resume to bill@fidelisbiopharm.com or call 972-770-7917.
