Supports Regulatory Affairs activities for Arthrex, Inc.
Essential Duties and Responsibilities:
With minimal supervision, prepares and writes 510(k) submissions and Letters-To-File
Act as the regulatory representative on product development teams for new and modified devices
Develops regulatory strategy for new and modified devices for U.S.
Reviews device changes to assess regulatory impact
Gathers information and data from other departments and external resources for regulatory submissions in both U.S. and Canada
Reviews and approves advertising and promotional materials
Participates in regulatory or quality systems audits as required
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.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Effective interpersonal and communication skills.
Strong interpersonal, oral and written communication skills required.
5+ years experience in writing 510(k) submissions and Letters To File required.
Proficient in Microsoft Office
Ability to work in fast paced environment
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.
Internal Number: 41288
About Arthrex, INC.
We are a global medical device company and leader in new product development and medical education in orthopaedics. With a corporate mission of helping surgeons treat their patients better, Arthrex has pioneered the field of arthroscopy and developed more than 8,500 innovative products and surgical procedures to advance minimally invasive orthopaedics worldwide.
Arthrex continues to experience unprecedented growth and demand for our products throughout the world; however, we remain a privately-held company with a family business culture that is committed to delivering uncompromising quality to the healthcare professionals who use our products, and ultimately, the millions of patients whose lives we impact.
We invite you to learn more about Arthrex and the positive contributions we are making to medicine and the communities we serve.