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Supports regulatory and compliance activities for Arthrex, Inc.
Essential Duties and Responsibilities:
Under supervision, prepares, writes and submits regulatory filings
Completes product registration activities
Gathers information and data from other departments and external resources for regulatory submissions
Supports other RA personnel with project deadlines in administrative and/or research roles
Maintains product information databases
With supervision, 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.
Education and Experience:
Associate’s Degree required, preferably in a Science or Engineering discipline.
1+ years of experience or training in medical device regulatory affairs is required.
Strong interpersonal, oral and written communication skills required.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Effective project Coordination skills
Effective interpersonal and communication skills
Proficient in Microsoft Office
Ability to work in fast paced environment and handle multiple projects
Ability to problem solve
Effective written communication skills
Basic understanding of regulatory framewrok, regulatory requirements
Basic understanding of orthopedic technical/ engineering/medical terminology
Machine, Tools, and/or Equipment Skills:
PC, database, research tools, internet research tools. MS Office skills.
Ability to problem solve. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skills:
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
Internal Number: 42160
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.