Arthrex is a privately held global medical device company that is a leader in new product development and medical education in orthopedics. Arthrex’s innovative spirit has pioneered the field of arthroscopy and sports medicine, and led to the development of more than 1,500 innovative products and procedures each year. More than 90% of Arthrex’s products are manufactured in the United States and exported to more than 100 countries around the world. Arthrex continues to experience unprecedented growth and demand for our products throughout the world.
Arthrex’s status as a privately-owned, non-listed company enables us to give priority to the needs of our customers for the good of their patients. Arthrex stands unwaveringly committed to its corporate mission, “Helping Surgeons Treat Their Patients Better”, by delivering uncompromising quality to the healthcare professionals who use our products, and ultimately, the millions of patients whose lives we impact.
Arthrex headquarters in Naples Florida, where this position will be located, which is approximately 2 miles from pristine white sandy beaches of the Gulf of Mexico and surrounded by state of the art golf courses; upscale shopping districts; numerous outdoor activities such as boating, fishing, kayaking, wildlife sanctuaries; and a restaurant scene that has been ranked in USA Today’s Top 10 Best Small Town Food Scenes in the USA for 2018. Additionally, in 2019 the USA Today’s Gallup Poll ranked Naples as one of the Top Ten Cities for Overall Wellbeing in the country for the fourth year in a row. Employees also benefit from Florida not having a state income tax on earned income.
Arthrex offers numerous exceptional benefits such as free on-site gourmet lunch Monday-Thursday, exclusive on-site medical center available to employees and their family, annual gym membership, company bicycles, and much more!
Arthrex proudly invests in the professional growth of its approximately 5,000 global employees through its commitment to provide on-going career development and training to further help employees’ careers. Arthrex prides itself on its strong, positive workplace culture that recognizes and rewards hard work and dedication.
Arthrex is mindful of the effect our corporate activity has on the earth, and we are committed to doing business in an environmentally-friendly manner. As part of our social responsibility, we strive to maintain customer satisfaction with the highest quality products developed in an environmentally sustainable way and create a working environment that supports these goals. We promote environmental impact reduction in all product development stages, product sales, and corporate facilities.
The Regulatory Affairs Associate will provide regulatory affairs support for Class I and Class II medical devices. The Regulatory Affairs Associate will assist the Regulatory Affairs Specialist on Product Development Team(s) and will be responsible for compiling and submitting necessary information, as directed, that leads to and maintains regulatory approval for medical devices in North America and Canada. Additionally, the Regulatory Affairs Associate is responsible for assisting the Regulatory Affairs Specialist in the assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes.
Essential Duties and Responsibilities:
With guidance, assist in the research, analysis and develop of regulatory strategy for FDA & Health Canada clearance of medical devices.
With guidance, assist in the review of any proposed product changes for impact on regulatory strategy and status.
With guidance, assist in evaluating risk of proposed regulatory strategies and offer solutions, as applicable.
As directed, assist Regulatory Specialist in advising and providing regulatory direction and recommendations to assigned Product Development Team(s) on the regulatory requirements, documentation and testing needed for FDA & Health Canada regulatory submissions/registrations during the development of new devices, device modifications, and changes to existing products.
With guidance, assist in teaming with Regulatory Affairs International Divisions staff to provide regulatory support for new products and changes to existing products.
As directed, assist in providing business and product information to Regulatory Affairs International Divisions staff to enable development of strategies and communicate that information to assigned Product Development Team(s).
As directed, assist in maintaining regulatory databases as well as preparing Regulatory Assessment form, Memos to File, documentation for the Product Development Team and other technical documentation as required for new and modified products.
As directed, assist in reviewing and approving all design control documentation, engineering change requests for design, manufacturing and labeling changes, and custom’s requests to ensure compliance with global regulations.
As directed, provide feedback and on-going support to Product Development Team(s) to resolve (potential) regulatory issues and questions from regulatory agencies.
As directed, assist in assembling/preparing information as well as writing and submitting FDA and Health Canada submissions for new products and product changes as required in accordance with established time-lines and submission dates to ensure timely approvals while in compliance with regulations.
With guidance, review regulatory documentation to ensure completeness, clarity, consistency, conformance to regulations and guidelines, and are accurate and verifiable against source documents to confirm compliance and traceability.
Coordinate and consult with Regulatory Specialist, manager and/or other departments on the content and review of regulatory documentation.
As directed, provide support to currently-marketed products as necessary. This includes providing guided assistance in: reviewing labeling; reviewing promotional material; reviewing product changes; preparing documentation for changes requiring government approval; and preparing submissions and reports for regulatory agencies as required by product status.
With direction and guidance interact directly with FDA and/or Health Canada on projects/products.
Establish, develop and maintain positive relationships with regulatory agency personnel.
Develop proficiency in applicable regulatory requirements and keep abreast of the development and changes to the applicable laws, regulations, and industry standards.
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 framework, 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.
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.