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:
- Develop regulatory strategies and implementation plans for the preparation and submission of new products and review any proposed changes for impact on regulatory strategy and status.
- May evaluate the risk of proposed regulatory strategies and offer solutions as applicable.
- Advise project teams on premarket regulatory requirements, such as documentation and testing needed, labeling requirements, or clinical study compliance issues.
- Provide project teams with on-going support to resolve any real or perceived regulatory issues.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes
- 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.
- Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
- Review and approve design control documentation, engineering change requests, manufacturing and labeling changes, and other applicable requests for adherence to global regulatory compliance.
- Review and approve product advertising/promotional materials, labeling, and/or test methods for compliance with applicable regulations and policies.
- Review or edit 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.
- Communicate with regulatory agencies with or without direction regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- 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, guidance's, policies, and/or procedures to stakeholders, as applicable.
- Review clinical protocols to ensure collection of data is sufficient for regulatory submissions.
- Recommend changes to company procedures in response to changes in regulations, guidance's and/or standards.
- Obtain and distribute updated information regarding domestic or international laws, guidance's and/or standards.
- Write or update standard operating procedures, work instructions, or policies.
- Participate in internal or external audits, as required.
- May develop or conduct employee regulatory training
Develops solutions to routine technical problems of limited scope.
Work is closely supervised. Follows specific detailed instructions.
Contributes to completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs.
Contacts are primarily with immediate supervisor, project leaders, and other professionals in the section or group.
- Limited use and/or application of technical principles, theories, and concepts.
- Basic knowledge of regulatory framework and regulatory requirements for one region.
- Basic knowledge of human physiology/anatomy and associated medical terminology.
- Basic knowledge of orthopedic terminology, surgery principles, theories and products.
- Basic knowledge of current medical device regulations, standards, guidance's and regulatory requirements for medical devices in region of specialization.
- Basic knowledge of 21 CFR 820/ISO 13485.
- Basic knowledge of product lifecycle, product development process, design control and change control.
- Basic knowledge of clinical trial strategy and study design, and sponsor reporting requirements.
- Experience in a regulatory affairs role in the life science industry preferred.
- Bachelor's degree preferred, engineering or science discipline preferred.
- Advanced degree preferred.
- Orthopedic medical device experience preferred.
- Regulatory Affairs Certification (RAC) preferred.
- Regulatory submission experience preferred.
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.
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.
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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