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Arthrex · 3 hours ago

Senior Specialist, Regulatory Affairs

Naples, FL

Full-time

Onsite

Senior Level

5+ years exp

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. We are seeking a Senior Specialist, Regulatory Affairs who will be responsible for managing product activities related to regulatory submissions and registration for Arthrex’s 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.

Health CareMedical Device

Comp. & Benefits

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

Qualification

Regulatory AffairsFDA submissionsMedical device experienceRegulatory Affairs CertificationExcel proficiencyMathematical skillsCommunication skillsProblem-solving skills

Required

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

Experience authoring and submitting medical device registrations/licenses/submissions applicable to regional area

Experience reviewing product labeling and advertising/promotional material for medical devices

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalent if changed by the Company), QAD or similar inventory software

Ability to define problems, collect data, establish facts, and draw valid conclusions

Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements

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