Regulatory Affairs Specialist I - Spine

Regulatory Affairs Specialist I - Spine

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. We are actively searching for a Regulatory Affairs Specialist I, Spine for our global headquarters in Naples, FL. The RA Specialist I – Spine is responsible for managing specific aspects of the Arthrex Regulatory Affairs program with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in the most efficient, compliant manner.

This position will play a critical role in regulatory approval efforts. In coordination with management of Regulatory Affairs, this role will develop regulatory strategy, execute the regulatory plan, and perform other activities that lead to and maintain regulatory approval/clearance/licensure for Arthrex's medical devices. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Provide project teams with on-going support to resolve any real or perceived regulatory issues.
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
• Coordinate, prepare, write, submit and/or review regulatory submissions for projects in accordance with established product launch or other applicable timelines.
• Coordinate efforts with regional counterparts associated with the preparation of international regulatory documents or submissions.
• Review regulatory documentation for completeness, clarity, consistency and conformance to regulation, guidelines and internal policies/procedures to ensure all data and information is truthful, accurate and verifiable against source documentation to confirm compliance and traceability.
• Establish, develop and maintain positive relationships with regulatory agency personnel.
• Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
• Maintain current knowledge base of existing and emerging regulations, standards, and/or guidance documents.
• Explain regulations, guidances, policies, and/or procedures to stakeholders, as applicable.
• Recommend changes to company procedures in response to changes in regulations, guidances and/or standards.
• Obtain and distribute updated information regarding domestic or international laws, guidances and/or standards.
• Write or update standard operating procedures, work instructions, or policies.
• Participate in internal or external audits, as required.

Education and Experience:

• Bachelor's degree required, engineering or science discipline preferred.
• Advanced degree preferred.
• Orthopedic medical device experience preferred.
• Regulatory Affairs Certification (RAC) preferred.

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.

Abilities Requirements:

• Ability to comprehend principles of engineering, physiology and medical device use.
• Ability to handle master documents, drawings, specifications, regulatory and clinical documentation with a high degree of confidentiality.
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
• Ability to review, collate, describe and summarize…