Senior Specialist, Regulatory Affairs - Medical Device Imaging Systems and SaMD (Remote Option Avail

Position Summary:

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Senior Specialist, Regulatory Affairs, who will provide regulatory affairs support for Class I and Class II medical devices with a focus on its Imaging & Resection product portfolio, which includes visual imaging systems and virtual implant positioners utilizing software as a medical device (SaMD). The Senior 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 the U.S. and Canada. Additionally, the Senior Specialist will be responsible for the assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. This position can be remote or based out of Santa Barbara, California, at the Arthrex California Technology location. 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™.

Regulatory Affairs Senior Specialist Duties and Responsibilities

• Develop U.S. 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 & Health Canada regulatory submissions and registrations during the development of new devices, device modifications, and changes to existing products.
• 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.
• 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 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 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.

Regulatory Affairs Senior Specialist Requirements

• 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.
• Regulatory Affairs Certification (RAC) preferred.
• Experience authoring and submitting medical device registrations/licenses/submissions.
• Experience reviewing product labeling and advertising/promotional material for medical devices.
• Clinical or statistical experience preferred.