Edwards Lifesciences Manager, Regulatory Affairs Program Management - Critical Care in Irvine, California
This Regulatory Affairs Program Management opportunity represents an excellent opportunity to join a high growth, innovative, and industry-leading organization. In this role, you will be part of a high performing Regulatory Affairs team responsible for the regulatory process to support multiple Critical Care products. Edwards has a strong pipeline in this space and the regulatory pathway is critical to getting these important products to our clinicians and patients. supporting projects for our critical care new product development products. We are looking for a diligent RA professional who works well across functional teams, takes initiative, and enjoys working in a fast-paced team environment.
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.
Identify and evaluate regulatory affairs process improvement and/or course correction/course alignment opportunities to accelerate the route to market access in collaboration with key stakeholders.
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.
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 on 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
Other incidental duties
Education and Experience:
A Bachelor’s degree in a related field is required; a scientific discipline is preferred.
A minimum of ten years of related experience is required with a Bachelor’s degree, OR, a minimum of eight years of related experience is required with a Master’s degree
Experience in preparing domestic and international product submissions for medical device products is 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
Recognized as an expert in own area with specialized depth within the organization
Expert knowledge and understanding of global regulations relevant to Class II and/or Class III medical devices
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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.