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ProfileManager, Regulatory Affairs - Critical Care Duties: Represents an excellent opportunity to join a high growth, innovative and industry leading organization and advance a career in the Regulatory Affairs function. Will be part of a high performing Regulatory Affairs team responsible for the regulatory process to support multiple Critical Care products. Represent Regulatory Affairs on a diverse array of new product development and manufacturing support teams with the goal of commercializing new and innovative Critical Care technologies, as well as ensuring the sustained success of marketed products. Will work on multiple projects where analysis of situations or data requires an evaluation of intangible variables for established products as well as new/emerging technology with no or limited history. Will demonstrate the ability to develop a variety of solutions to regulatory challenges and will exercise independent judgment in determining and communicating appropriate regulatory action and requirements. Will involve assessment of regulatory impact for new and modified Class I, II and III products, including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans. The role requires strategic planning, preparation and management of regulatory submissions for US, EU and/or International submissions (e.g. 510(k)s and Letters to File, De Novo applications, FDA Pre-Submissions, CE Technical Files and Design Dossiers, and Change Notifications). Will collaborate with cross-functional teams, make presentations to management teams, and mentor Regulatory Affairs team members to share regulatory affairs knowledge. Will interact directly with Regulatory Agencies under management guidance. Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Represent Regulatory Affairs on project teams and in management meetings. Act as liaison with government officials in support of product approvals. Communicate and maintain productive constructive relationships with Edwards Lifesciences internal cross-functional teams and external customers as required (e.g. US FDA, Notified Bodies, in-country regulatory representatives, distributors, consultants, etc.). Review and approve design, development, software/hardware and operations protocols/reports and change orders. Assume regulatory review of promotional material, labeling content, product and process changes and product documentation. Ensure schedules and performance requirements are met. Manage and mentor junior members of the Regulatory Affairs team. Monitor proposed and current global regulations and guidance; advise on impact of such regulations and guidance on the company within the scope of assigned projects.
Qualification and Experience
Qualifications: A Bachelor’s degree is required, preferably in a scientific discipline. An advanced degree in the sciences, Ph.D., or a combination of an MBA or JD Degree with a science degree is preferred. Requires 10+ years’ experience in Regulatory Affairs. Medical device experience in other areas may be considered. Experience in reviewing new and modified products for regulatory impact, determining appropriate global regulatory requirements, and preparing domestic FDA and EU product submissions is required. Demonstrated competence in working as part of a focused project team. Demonstrated understanding of basic regulatory requirements for promotional materials. Experience in review and approval of promotional materials is a plus. Requires a strong working knowledge of US/EU regulations that affect Class I, II and III devices; and a good understanding of global regulations. Excellent writing and verbal communication skills; and strong strategic thinking, problem-solving and analytical ability. Ability to influence others at all levels of the organization is essential. Well-versed in program and project management, and new product development best practices. Continuously develops the talents of self and others for current and future business needs; motivates self and others to achieve high performance. Well-organized and accustomed to maintaining excellent records.