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Regulatory Affairs Specialist in Naples, FL ,  at Arthrex

Date Posted: 6/26/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Naples, FL
  • Job Type:
    Other
  • Experience:
    Not Specified
  • Date Posted:
    6/26/2018

Job Description


Requisition ID:
41288
Title:
Regulatory Affairs Specialist
Division:
Arthrex, Inc.
Location:
INC- Naples, FL

Main Objective:

Supports Regulatory Affairs activities for Arthrex, Inc.

Essential Duties and Responsibilities:

  1. With minimal supervision, prepares and writes 510(k) submissions and Letters-To-File
  2. Act as the regulatory representative on product development teams for new and modified devices
  3. Develops regulatory strategy for new and modified devices for U.S.
  4. Reviews device changes to assess regulatory impact
  5. Gathers information and data from other departments and external resources for regulatory submissions in both U.S. and Canada
  6. Reviews and approves advertising and promotional materials
  7. Participates in regulatory or quality systems audits as required

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

Bachelors degree required, masters degree preferred.

5+ years experience in writing 510(k) submissions and Letters To File required.

Strong interpersonal, oral and written communication skills required.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

  • Effective interpersonal and communication skills
  • Proficient in Microsoft Office
  • Ability to work in fast paced environment
  • Strong written communication skills
  • Ability to independently manage multiple projects over extended periods of time
  • Internal and external communication and collaboration skills
  • Comprehensive understanding of orthopedic technical/ engineering/medical terminology

Machine, Tools, and/or Equipment Skills:

PC, database, research tools, internet research tools.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.