Regulatory Affairs Senior Principal, Med Device Imaging Systems & SaMD (Remote)

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 Regulatory Affairs Senior Principal, 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 Principal 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 Sr. Principal will be responsible for the assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™.

We prefer for 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!  Full-time remote option available for candidates with a demonstrated history of effectively WFH.

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 Principal Requirements

• 15 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.

Knowledge and Skill Requirements/Specialized Courses and/or Training: 

Advanced knowledge of FDA 21 CFR 820, cGMP, and ISO13485:2016 required. 

Expert knowledge of product life-cycle, product development process, design control and change control

Advanced knowledge of quality control, inspection, and electro-mechanical testing equipment required. 

Experience with business or technical writing preferred. 

Advanced knowledge of and experience with applying probability or statistical tools preferred. 

Excellent and proven interpersonal and communication skills preferred. 

Reasoning Ability: 

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of writings, technical instructions in mathematical or diagram form, communications, and deal with several abstract and concrete variables. 

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. 

Arthrex 2023 Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Gym Reimbursement Program
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

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.