The Manager, Regulatory Affairs role on the Edwards Transcatheter Heart Valve product sustaining team represents an excellent opportunity to join a high growth, innovative and industry-leading organization and advance a career in the Regulatory Affairs function. The candidate we seek will demonstrate the ability to develop a variety of solutions to regulatory challenges and will exercise independent judgment in determining appropriate regulatory action and requirements for product changes and preparation of regulatory documents.
* Develop and plan multiple regulatory affairs projects and activities including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion of all project deliverables. Includes representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including providing alternatives for meeting regulatory requirements and resolving complex conflicts between those requirements and development issues.
* Review and approve protocols, reports, engineering drawings, procedures, labeling and other product development and manufacturing documentation to ensure compliance with regulatory requirements, consistency and accuracy.
* Provide direction and guidance to project teams to execute tactical regulatory affairs projects and/or initiatives. Includes preparation and oversight of larger documentation packages for submission to regulatory agencies. Track timelines and documents for inclusion in regulatory submissions. Interact with regulatory agencies as part of submission review and on-site audit support.
* Identify and evaluate regulatory affairs process improvement and/or course correction/course alignment opportunities to accelerate route to market access in collaboration with key stakeholders.
* Develop strategies and contingency plans for projects, including those that are most complex and challenging
* May anticipate and advise on future regulatory trends and direction, and recommend preemptive approaches for company regulatory compliance
* May act as a key member in RA committee (e.g., AdvaMed, standards/committee) and provide input in the development of standards/regulations that affect the Medical Device industry
* May review promotional material and labeling content to ensure compliance with regulatory requirements, consistency and accuracy
* A Bachelor's degree is required; scientific discipline is preferred. A Master's degree is preferred
* A minimum of 10 years of previous related experience is required; With a master's degree, 8 years of previous related experience is required; Experience preparing domestic and international product submissions is preferred
* Expert knowledge and understanding of global regulations relevant to Class II and/or Class III medical devices is required
* Recognized as an expert in own area with specialized depth within the organization
* Coursework, seminars, and/or other formal government and/or trade association training required
* Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
* Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
* Excellent problem-solving, organizational, analytical and critical thinking skills
* Expert knowledge and understanding of global regulatory requirements for new products or product changes.
* Expert knowledge of new product development systems
* Strong leadership skills and ability to influence change
* Strict attention to detail
* Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
* Ability to manage competing priorities in a fast paced environment
* Represents leadership on projects within a specific area interfacing with project managers and regulatory affairs team
* Consult in project setting within specific regulatory affairs area
* Provides regulatory affairs leadership to outsourcing partners on a task level, and may participate on small scale RFP
* Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control