Teleflex
Regulatory Affairs Specialist
The Regulatory Affairs Specialist will develop strategies and submissions for projects and issues related to regulatory documents, global submissions, investigations, product development planning, and regulatory agency interaction for the Surgical portfolio. Submissions will be moderate to complex and relate to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction. The incumbent is also responsible for staying abreast of evolving global regulatory requirements. Develop regulatory strategies for new products from development to launch for moderate-complexity projects and ensure appropriate data collection for regulatory submissions and compliance. Review and assess change control activities for potential impact on current regulatory filings. Ensures compliance with design controls, reviews design documentation to ensure that it meets regulatory requirements, and provides regulatory expertise and oversight to design teams. Interpret existing regulations and guidance documents within the regulatory department and on project teams. Understand and communicate regulatory requirements and what they mean to the organization and management. Identify risk factors and contingency planning for assigned projects. Interact with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks. Interface with FDA, Notified Bodies, or other national health agencies regarding new products and significant product changes as needed. Assume full responsibility for project submissions, from guidance/strategies/authoring/obtaining approvals, including 510(k) premarket notifications, EU MDD/MDR Technical Files, and/or other documentation required for registration/licensure of products outside the U.S. Develop timelines, coordinate receipt of technical information from appropriate sources, and manage the preparation of responses to regulatory agency questions and/or requests for information. Review and approve all Labeling (product, advertising, and promotional) verbiage and evaluate for any regulatory impact. Apply understanding of the quality systems to job activities and projects. Participate in training RA team members and others on compliance matters. Brings Regulatory Affairs questions/issues to the attention of RA management. Comply with Teleflex's Code of Ethics, including all company policies, rules, procedures, and housekeeping standards. Bachelor's degree in a science or engineering field is preferred. 2-3 years of regulatory affairs experience in a regulated environment is required. Basic understanding of, or experience with, medical devices with electrical capabilities is a plus. Regulatory affairs experience in domestic and international submissions, with 2-3 years of overall class I or II medical devices, is highly preferred. RAC certification is a plus Strong analytical and critical thinking skills Strong communication skills (both verbal and technical writing) Strong organizational and time management skills with a high level of personal and professional integrity and trustworthiness Strong work ethic and the ability to work independently, manage multiple projects with minimal direction, and meet deadlines. Orientation to teamwork, problem-solving ability, customer focus, and a commitment to quality Knowledge of electronic document management systems Basic understanding of, and ability to comply with, business and Regulatory Affairs ethical standards. Proficient in MS Word, Excel, PowerPoint, and Outlook required.
The Regulatory Affairs Specialist will develop strategies and submissions for projects and issues related to regulatory documents, global submissions, investigations, product development planning, and regulatory agency interaction for the Surgical portfolio. Submissions will be moderate to complex and relate to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction. The incumbent is also responsible for staying abreast of evolving global regulatory requirements. Develop regulatory strategies for new products from development to launch for moderate-complexity projects and ensure appropriate data collection for regulatory submissions and compliance. Review and assess change control activities for potential impact on current regulatory filings. Ensures compliance with design controls, reviews design documentation to ensure that it meets regulatory requirements, and provides regulatory expertise and oversight to design teams. Interpret existing regulations and guidance documents within the regulatory department and on project teams. Understand and communicate regulatory requirements and what they mean to the organization and management. Identify risk factors and contingency planning for assigned projects. Interact with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks. Interface with FDA, Notified Bodies, or other national health agencies regarding new products and significant product changes as needed. Assume full responsibility for project submissions, from guidance/strategies/authoring/obtaining approvals, including 510(k) premarket notifications, EU MDD/MDR Technical Files, and/or other documentation required for registration/licensure of products outside the U.S. Develop timelines, coordinate receipt of technical information from appropriate sources, and manage the preparation of responses to regulatory agency questions and/or requests for information. Review and approve all Labeling (product, advertising, and promotional) verbiage and evaluate for any regulatory impact. Apply understanding of the quality systems to job activities and projects. Participate in training RA team members and others on compliance matters. Brings Regulatory Affairs questions/issues to the attention of RA management. Comply with Teleflex's Code of Ethics, including all company policies, rules, procedures, and housekeeping standards. Bachelor's degree in a science or engineering field is preferred. 2-3 years of regulatory affairs experience in a regulated environment is required. Basic understanding of, or experience with, medical devices with electrical capabilities is a plus. Regulatory affairs experience in domestic and international submissions, with 2-3 years of overall class I or II medical devices, is highly preferred. RAC certification is a plus Strong analytical and critical thinking skills Strong communication skills (both verbal and technical writing) Strong organizational and time management skills with a high level of personal and professional integrity and trustworthiness Strong work ethic and the ability to work independently, manage multiple projects with minimal direction, and meet deadlines. Orientation to teamwork, problem-solving ability, customer focus, and a commitment to quality Knowledge of electronic document management systems Basic understanding of, and ability to comply with, business and Regulatory Affairs ethical standards. Proficient in MS Word, Excel, PowerPoint, and Outlook required.