Apply on Employer Site

Arthrex · 2 weeks ago

International Regulatory Affairs Senior Specialist (EMEA)

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. The International Regulatory Affairs Senior Specialist will advance Arthrex’s global market access by providing technical support to subsidiaries and distributors to achieve and maintain regulatory approvals for medical devices while ensuring compliance.

Health CareMedical Device

Comp. & Benefits

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

Qualification

Regulatory AffairsMedical Device ExperienceTechnical DocumentationSAPMicrosoft Office SuiteTeam CollaborationProblem SolvingCommunication Skills

Required

Bachelor's degree required

5+ years relevant experience supporting medical device registrations/licenses/submissions and quality audit requests applicable to assigned area

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

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

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)

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