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Regulatory Operations Specialist I

Company: Merit Medical Systems, Inc.
Location: South Jordan
Posted on: June 10, 2021

Job Description:

SUMMARY OF DUTIES

This position is responsible for the creation, support, and improvement of global regulatory operations, systems, and processes.

ESSENTIAL FUNCTIONS PERFORMED

  • Assist with determining global strategies for various field action activities.
  • Assist with, coordinate, and execute global field actions, per internal policies and procedures.
  • Develop, maintain, and update field action files per internal policies and procedures.
  • Coordinate and prepare documents to support regulatory submissions and certifications as requested.
  • Develop, maintain, and improve global regulatory processes, systems, and procedures, and provide training when needed.
  • Work closely with global functions and departments to integrate processes and meet global regulatory needs.
  • Provide updates to, and interact with, various levels of management, external agencies, and customers as requested.
  • Prepare correspondence to FDA, Competent Authorities and other regulatory authorities as requested.
  • Participate in and assist with FDA facility inspections, Notified Body Audits and other inspections and audits as directed.
  • Remain current with global regulations, guidance documents, and standards and assist with global implementation, integration, and training when needed.
  • Perform other duties and tasks, as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

  • Lifting -- Not to exceed 50 lbs. -- local practice may apply.
  • Writing
  • Sitting
  • Standing
  • Bending
  • Visual acuity
  • Color perception
  • Depth perception
  • Reading
  • Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

  • Education and/or experience equivalent to a Bachelor's degree in a technical field such as in the biological, physical, engineering, material science, regulatory, or legal disciplines.
  • Basic project management, process development, and process improvement skills.
  • Basic technical writing skills.
  • Self-motivated, self-directing, strong attention to detail and time management skills.
  • Excellent interpersonal skills and the ability to communicate well -- verbal and written.
  • Strong computer skills: spreadsheets, word processing, database, research, and other applicable software programs.

PREFERRED QUALIFICATIONS

  • Medical device industry experience.
  • Quality systems experience.

COMPETENCIES

  • Analytical, critical, and strategic thinking
  • Problem-solving
  • Interpersonal/communication/training skills
  • Technical writing
  • Project management
  • Process development
  • Process improvement
  • Computer, software, database skills

COMMENTS

Infectious Control Risk Category: III

The risk category explains whether employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.

Keywords: Merit Medical Systems, Inc., South Jordan , Regulatory Operations Specialist I, Other , South Jordan, Utah

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