Quality/Risk Management, Research & Development, Submission & Registration, US Regulatory Affairs
4 Year Degree
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.
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.
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.
Internal Number: 41288
About Arthrex, Inc.
Incorporated since 1984, Arthrex has been a privately held corporation committed to just one thing: providing the finest quality products and educational services to meet the special needs of orthopaedic surgeons and their patients. Arthrex has a focused dedication to creative product development and medical education with an experienced, devoted team of professionals who are truly committed to continuing this tradition.
New product innovation in arthroscopic surgery is the heart and soul of Arthrex, which has resulted in the development of over 6,000 products for arthroscopic and minimally invasive orthopaedic surgical procedures. Our goal is to make technically demanding surgical procedures easier, safer and reproducible.
Investing in Arthrex products means you have chosen a company committed to uncompromising quality and constant product innovation while providing you with the most competent technical customer support in the industry. Today our products are distributed throughout the U.S. and in over 60 countries worldwide.