Manager of Regulatory Affairs Gainesville, FL area
Kelly Scientific resources is looking for a Regulatory Affairs/Submissions Manager for a medical device company near Gainesville, FL. This is a direct hire role. Monday-Friday on the 1st shift.
The Manager of Regulatory Affairs is responsible for the planning and conduct of all matters associated with Regulatory Affairs, including the generation and submission of all Regulatory documentation in support of Company products.
Vice President of Operations
Manage domestic and international regulatory compliance activities of the Company
Generate all submissions for attaining device regulatory clearance, including FDA 510(k) Premarket Notifications, CE Technical Files, and Canadian Device License Applications.
Prepare and provide supporting regulatory documentation to company distributors to insure device clearance in international markets.
Maintain FDA, CE, and other associated regulatory registrations and licenses.
Maintain accurate and up-to-date knowledge in terms of national and international reference documents as they pertain to device regulations.
Serve as the RA interface with Product Development and provide input on regulatory requirements as they pertain to new product development and clearance.
Maintain distributor regulatory requests and supplier evaluation files.
Assemble Management Review content and resulting corrective/preventive actions.
Perform other duties as assigned and participate as part of the corporate team.
Minimum Skill Requirements:
Experience with FDA, CE, and ISO regulations and requirements
Ability to rely on extensive experience and judgment to plan and accomplish goals.
Ability to the work with others in a team environment
Excellent time management skills, including project management
Attention to detail
Excellent problem-solving ability
Computer aptitude; proficient with MS Office (Word, Excel, PowerPoint)
Master’s Degree with six years Regulatory experience or Bachelor’s degree with ten years experience
Experience in Class II or Class III implantable medical device industry preferred