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Regulatory Affairs Specialist in Naples, FL , at Arthrex
Regulatory Affairs Specialist
Come Join the Arthrex Family!
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 Specialist will provide regulatory affairs support for Class I and Class II medical devices. The Regulatory Affairs Specialist will be the regulatory representative on Product Development Team(s) and will be responsible for regulatory strategy, execution, and activities that lead to and maintain regulatory approval for medical devices in North America and Canada. Additionally, the Regulatory Affairs Specialist is responsible for the assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes.
Essential Duties and Responsibilities:
- Develop regulatory strategy for FDA & Health Canada clearance of medical devices.
- Evaluate the risk of proposed regulatory strategies and offer solutions, as applicable.
- Advise and provide regulatory direction to assigned Product Development Team(s) on the regulatory requirements, documentation and testing needed for FDA & Health Canada regulatory submissions and registrations during the development of new devices, device modifications, and changes to existing products.
- Team with Regulatory Affairs International Divisions staff to provide regulatory support for new products and changes to existing products.
- Provide 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).
- Review and approve all design control documentation, engineering change requests for design, manufacturing and labeling changes, and custom’s requests to ensure compliance with global regulations.
- Provide feedback and on-going support to Product Development Team(s) to resolve (potential) regulatory issues and questions from regulatory agencies.
- Prepare, write, and submit 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.
- Rigorously review regulatory documentation to ensure completeness, clarity, consistency, and conformance to regulations and guidelines.
- Coordinate and consult with manager and/or other departments on the content and review of regulatory documentation.
- Provide support to currently-marketed products as necessary. This includes: 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.
- Represent the company with regards to regulatory strategies, submissions, and discussions/negotiations with FDA and/or Health Canada, as applicable.
- Interact directly with FDA and/or Health Canada on projects/products at reviewer level.
- Establish, develop and maintain positive relationships with regulatory agency personnel.
- Maintain proficiency in applicable regulatory requirements.
- Assist in mentoring new hires as requested by management.
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 direct experience and training in Regulatory Affairs required.
5+ years experience in writing regulatory submissions 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
- Advanced understanding of regulatory framework and regulatory requirements for at least one region
- Basic understanding for at least one additional region
- 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.