Senior Specialist, Regulatory Affairs - International (EMEA)

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Specialist, International Regulatory Affairs for our Global Headquarters in Naples, FL. The International Regulatory Affairs Senior Specialist will advance Arthrex’s global market access by providing technical support to Arthrex subsidiaries and distributors to achieve and/or maintain regulatory and quality approval/clearance/registration/licensure/certifications for Arthrex’s medical devices in the most efficient and least burdensome approach to meet business needs while maintaining compliance. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties And Responsibilities

• Research and respond to inquiries from Arthrex subsidiaries and distributors to facilitate new product registrations, license renewals, re-registrations, design change notifications, manufacturing and labeling changes, customs requests, international marketing bid/tenders and to support quality tasks related to foreign manufacturer registrations.
• Coordinate with Engineering, R&D, Manufacturing, Quality Assurance, and other applicable departments to collect technical information and data associated with the preparation of international regulatory documents to support Arthrex subsidiaries and distributors new product registrations, license renewals, re-registrations, design change notifications, manufacturing and labeling changes, customs requests and international marketing bid/tenders.
• Provide technical review of data or reports to be provided to regulatory agencies to ensure scientific rigor, accuracy, clarity of presentation, completeness, consistency, and conformance to regulations and guidelines and internal policies/procedures to ensure all data and information is truthful, accurate and verifiable against source documentation to confirm compliance and traceability.
• Manage and process requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sale, and Certificates of Exportability.
• Provide feedback and on-going support to Arthrex subsidiaries and distributors to resolve (potential) regulatory issues and inquiries from regulatory agencies - offering solutions, as applicable.
• Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
• Partner with in-country Regulatory and Quality staff to identify international regulations, guidances, policies, and/or procedures for changes and ensure change notification to Regulatory leadership and appropriate stakeholders.
• Recommend changes to company procedures in response to changes in regulations, guidances and/or standards.
• Write or update standard operating procedures, work instructions, or policies.
• Participate in internal or external audits.
• Develop and/or conduct employee training for International Regulatory Affairs.
  
  

Education And Experience

• Bachelor's degree required
• 5 years relevant experience supporting medical device registrations/licenses/submissions and quality audit requests applicable to assigned area.
  
  

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 organize complex information and combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events) to produce answers that make sense. 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 utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one. 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 scientific and technical data. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments. Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.

Machine, Tools, And/or Equipment Skills

Proficiency in the use of personal computers and computer programs, particularly SAP, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

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.