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Regulatory Affairs Specialist

Fort Worth Metro Area, TX

Post Date: 06/19/2018 Job ID: JN -062018-21866 Job Type: Scientific
  • Works in close collaboration with internal stakeholders and supports multiple products.
  • Provides high quality global support for all marketed products through global expansion efforts and maintenance of approved products.
  • Partners with regions to assess and provide support documentation needs (e.g., certificates).
  • Ensures compliance with global regulatory requirements and adherence to internal policies and processes, and coordinates compliance activities at a global level.
  • Provides support as needed for non-project related regional excellence activities.Implement and support Regulatory Impact Assessment Requests and global registrations required as a result of the Medical Device Regulation (MDR) implementation.
  • Demonstrates ability to coordinate and work effectively with cross functional teams.
  • Ensures timely, clear communication on project and regulatory approval status, issues, and risks with teams, GRA line management, key internal stakeholders, and with Health Authorities.
  • Serve as role model and embrace Corporate Values and Behaviors.
  • Committed to drive efficiency while maintaining quality
  • Demonstrates good organizational and time management skills, the ability to work on multiple projects, and adherence to timelines
  • Meets individual goals as defined in annual objectives
  • medical devices
  • outside United States medical device registrations
  • EU Technical Files
  • CE Marking
  • medical device lifecycle management
  • Class III US PMA
  • Class IIb EU Classification
  • Bachelor's Degree

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