Posted in Information Technology 30+ days ago.
Type: Full-Time
Requisition ID: | 48018 |
Title: | Regulatory Affairs Specialist I |
Division: | Arthrex, Inc. (US01) |
Location: | INC - Arthrex One (US33) |
Main Objective: 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.
Essential Duties and Responsibilities:
Problem Solving
Develops solutions to routine technical problems of limited scope.
Discretion/Latitude
Work is closely supervised. Follows specific detailed instructions.
Impact
Contributes to completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs.
Liaison
Contacts are primarily with immediate supervisor, project leaders, and other professionals in the section or group.
Knowledge
Education/Experience
Incidental Duties:
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
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 scientific and technical data. 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 utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one. 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.
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.
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