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Job Runner

 
  • Category: Healthcare
  • Education: Bachelors Degree
  • Employment Length: fulltime
  • Source: Business
  • Ad #: 11547
 
Via: kellyjobsmnetwork Apply / More Info
 
Full Details
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. General Description:  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. Reports to:

Vice President of Operations

Responsibilities:
  • 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
  • Interpersonal skills
  • Attention to detail
  • Excellent problem-solving ability
  • Computer aptitude; proficient with MS Office (Word, Excel, PowerPoint)

Education/Training:

  • 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

 

 

 
Map: Alachua FL
 
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