Regulatory Affairs Specialist II (LATAM) Med Devices

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics.  Arthrex is actively seeking an International Regulatory Affairs Specialist II who will provide regulatory affairs support for device registrations in Latin America.  This position reports to the Manager of Regulatory Affairs Latin America Division and is based out of the Arthrex headquarters in Naples, Florida.  Relocation assistance is 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™.

We would like this position to sit with us in our Corporate Headquarters in Naples to work directly with the team with a partial-flexible WFH policy.  Generous relocation package offered!  

Duties and Responsibilities:

• Coordinates and collects specific registration information with Engineering, R&D, Manufacturing, Quality Assurance, and other applicable departments as necessary to support device registration requirements in Latin America.
• Assembles technical information to create device registration dossiers.
• Manage document and registration requests from in-country Arthrex subsidiaries.
• Coordinates timely preparation of requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sale, and Certificates of Exportability.
• Evaluate the risk of proposed regulatory strategies and offer solutions, as applicable.
• Team with Regulatory Affairs International Divisions staff to provide regulatory support for changes to existing products.
• Review engineering change requests for design, manufacturing and labeling changes, and customs requests to ensure compliance with global regulations.
• Provide feedback and on-going support to the global Regulatory Affairs team to resolve (potential) regulatory issues and questions from regulatory agencies.
• 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.

Requirements:

• Fluency in Spanish and/or Portuguese.
• 2 years relevant experience required, preferably in a regulatory affairs role in the life science industry.
• Bachelor’s degree required.
• Experience authoring and submitting medical device registrations/licenses/submissions.

Reasoning Ability:

Ability to identify and define problems, collect data, analyze established facts, draw valid conclusions, and effectively communicate the information both verbally and in writing to a variety of audiences.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to both appropriately format and develop a clear logic trail to establish conclusions based on an understanding of factual evidence. Ability to critically think; using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Ability to actively learn; understanding the implications of new information for both current and future problem-solving and decision-making.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of personal computers and computer programs, particularly SAP, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company). 

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.

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.