Manager, Regulatory Affairs - LATAM

Requisition ID: 47494 Title: Manager, Regulatory Affairs - LATAM Division: Arthrex, Inc. (US01) Location: INC- Naples FL (US08)

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Manager, Regulatory Affairs - Latin America. The position is based at the Arthrex world headquarters campus in Naples, Florida. Relocation assistance may be available along with Arthrex's exceptional employee benefits and work culture. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Position Summary:

Responsible for leading Latin America regulatory staff and product registrations, including preparing regulatory strategies and managing regulatory submissions.

Duties and Responsibilities

• Lead and manage day to day activities and Latin America regulatory staff;
• Determine and support regulatory activities which lead to and maintain regulatory compliance and approval for Arthrex devices in Latin America;
• Support and advise cross-functional teams and communicate regulatory requirements and challenges effectively to meet project needs;
• Monitor Latin American regulations/guidelines and the impact of changing/evolving regulations on submissions, practices, and procedures, and communicate to appropriate stakeholders.
• Oversee and direct the development of priorities, timelines, receipt of technical information from appropriate sources, and the preparation of regulatory submissions for new products, amendments of approved products, and submissions that support the maintenance of existing licenses;
• Review and evaluate issues which may create regulatory or business obstacles, and propose solutions;
• Review and approve marketing literature for Latin America;
• Allocation of resources and workloads;
• Assist in regulatory due diligence, as needed;
• Deliver regular updates of all relevant regulatory activities and issues to the Senior Manager of Regulatory Affairs, The Americas.

Education/Experience:

• Bachelor's degree required.
• Advanced Degree (MS or PhD, or equivalent) preferred; preferably in a Science or Engineering discipline.
• 5 years direct experience in Regulatory Affairs in a Medical Device Company required. Orthopedics preferred.
• 3 years management experience required.
• Training in technical aspects of regulatory affairs required.
• Regulatory experience in U.S. required, OUS experience is highly desirable.

Knowledge:

• Advanced knowledge of regulatory framework and regulatory requirements for Latin America.
• Novice knowledge of human physiology/anatomy and understanding of relevant procedures, practices, and associated medical terminology.
• Intermediate knowledge of orthopedic terminology, surgery principals, theories, and products.
• Advanced knowledge of current medical device regulations, standards, guidance's and regulatory requirements for medical devices in Latin America.
• Advanced knowledge of ISO 13485.
• Advanced knowledge of product lifecycle, product development process, design control and change control.
• Intermediate knowledge of clinical trial strategy and study design, and sponsor reporting requirements.

Skills/Ability:

• Strong interpersonal and communication skills.
• Ability to work in fast paced environment.
• Advanced written communication skills.
• Ability to plan, evaluate, and improve the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output.
• Internal and external communication and collaboration skills.
• Knowledge and experience in business, supervision, and management.
• Ability to lead, develop, and effectively manage employees.
• Strong interpersonal relationship building and employee coaching/ development skills.
• Proficiency with Microsoft Office, Adobe, etc.

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 1,000 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, exclusive access to onsite fitness facilities, company bicycles, and much more!

Arthrex proudly invests in the professional growth of its approximately 3000 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.

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.

Job Requirements: