Senior Specialist, Regulatory Affairs - I&R (Remote)

 Requisition ID:          62865 Title: Senior Specialist, Regulatory Affairs - I&R (Remote) Division: Arthrex, Inc. (US01) Location: Remote Salary Range: Salary Minimum: 90,000 Salary Maximum:  131,000

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. We are seeking a Regulatory Affairs Senior Specialist who will be responsible for managing product activities related to regulatory submissions and registration for Arthrex’s Imaging and Resection product lines. This position plays a critical role in regulatory approval efforts by developing regulatory strategy, executing regulatory plans, and performing other activities that lead to and maintain regulatory approval/clearance/licensure for Arthrex's medical devices. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better.

This is a remote position. Candidate can work anywhere in United States.

 

Duties and Responsibilities:

• Develop U.S., EU and Canada regulatory strategy and implementation plans for the preparation and submission of new products and review any proposed changes for impact on regulatory strategy and status.
• 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, EU MDR & Health Canada regulatory submissions and registrations during the development of new devices, device modifications, and changes to existing products.
• Prepare, write, and submit FDA, Notified Body 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.
• Partner with International Regulatory Affairs to provide regulatory support for new products and changes to existing products.
• Provide business and product information to International Regulatory Affairs to enable development of strategies and communicate that information to assigned Product Development Team(s).
• Review and approve design control documentation, 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 Product Development Team(s) 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.
• Interact with FDA, Notified Bodies and/or Health Canada on products at reviewer level.
• Establish, develop and maintain positive relationships with regulatory agency personnel.
• Maintain proficiency in applicable regulatory requirements.

 

Education/Experience

• 5+ years relevant experience required preferably in a regulatory affairs role in the life science industry.
• Bachelor’s degree required, engineering or science discipline preferred.  Advanced degree preferred.
• Orthopedic medical device experience preferred.
• Working knowledge of IEC 60601-1, IEC 62304 and EU RoHS/REACH preferred.
• Regulatory Affairs Cert