Regulatory Operations Specialist I
Company: Merit Medical Systems, Inc.
Location: South Jordan
Posted on: June 10, 2021
SUMMARY OF DUTIES
This position is responsible for the creation, support, and
improvement of global regulatory operations, systems, and
ESSENTIAL FUNCTIONS PERFORMED
- Assist with determining global strategies for various field
- 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
- 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
- Visual acuity
- Color perception
- Depth perception
- 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
- Basic project management, process development, and process
- 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.
- Medical device industry experience.
- Quality systems experience.
- Analytical, critical, and strategic thinking
- Interpersonal/communication/training skills
- Technical writing
- Project management
- Process development
- Process improvement
- Computer, software, database skills
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
Keywords: Merit Medical Systems, Inc., South Jordan , Regulatory Operations Specialist I, Other , South Jordan, Utah
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