Regulatory Affairs Specialist
Fort Worth Metro Area, TX
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
3 years directly related experience