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Global Regulatory Affairs Sr. Specialist, EU MDR

Fort Worth, TX 76134

Posted: 11/02/2022 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 510920 Pay Rate: 42.86 Is job remote?: No Country: United States

Job Description

The Sr. Regulatory Specialist is responsible for the implementation and maintenance of the defined 
regulatory strategy, under limited supervision
  • Works in close collaboration with internal stakeholders and supports multiple projects
  • Provides support as needed for non-project related "regulatory excellence" activities
  • Ensures compliance with global regulatory requirements and adherence to internal policies and  processes
  • Responds to regulatory requests from across the organization in a timely manner
  • Provides high quality regulatory support for assigned products/projects
  • Partners with internal stakeholders (e.g., regions) to align on an optimized regulatory strategy in order to  achieve business objectives
  • Develops training programs for internal stakeholders, as needed
  • Develops documents that are clear, concise, and complete to facilitate reviews/approvals
  • Demonstrated ability to coordinate and work effectively with multiple stakeholders
  • Ensures timely, clear communications to internal stakeholders on project status and issues
  • Serves as role model and embraces corporate Values and Behaviors
  • Demonstrated good organizational and time management skills, including the ability to work on multiple  projects and adhere to timelines
  • Meets individual goals as defined in the annual objectives
  • Ability to support the business by communicating effectively, managing issues proactively, resolving  conflicts and mitigating risks
  • Ability to work in a matrixed environment and influence internal partners to achieve desired business  outcomes
  • Strong writing skills in the form of high quality regulatory submission documents
  • Committed to drive efficiency while maintaining quality
  • Drives superior results by taking initiative, planning and implementing projects, setting priorities and  holding self and others accountable to meet commitments
Minimum requirements
  • BS - 2 years of related experience
  • -or-
  • MS - 0 years of related experience

Pay ranges between $35-42/hr  **salary will be commensurate with experience**
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