Edwards Lifesciences Sr Manager, Regulatory Affairs - Surgical Structural Heart (Irvine, CA) in Irvine, California
Manage all Regulatory Affairs activities within the respective country(is).
• Develop and plan multiple complex and/or advanced 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. May include representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, 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 complex and/or advanced regulatory affairs process improvements and/or course correction/alignment opportunities to accelerate route to market access in collaboration with key stakeholders.
• Develop and plan strategies and contingency plans for projects, including those that are most complex and challenging.
• Provide direction and guidance to project teams to execute complex and/or advanced regulatory affairs projects, initiatives and/or programs. May include preparation and oversight of documentation packages for submission to regulatory agencies. Interact with regulatory agencies as part of submission review and on-site audit support.
• Anticipate and advise on future regulatory trends and direction, and frequently recommend preemptive approaches for company regulatory compliance
• Act as a key member in RA committee (e.g., AdvaMed, standards/committee) and provide input and influence on the development of standards/regulations that affect the Medical Device industry
• Review promotional material and labeling content to ensure compliance with regulatory requirements, consistency and accuracy
• Other incidental duties
Education and Experience:
Bachelor's Degree in in related field , 12 years years experience of previous related experience Required
Coursework, seminars, and/or other formal government and/or trade association training Required
Master's Degree or equivalent in in related field Experience in preparing domestic and international product submissions Preferred
Other: in scientific discipline (e.g., Biology, Microbiology, Chemistry) Preferred
• 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 one or more areas with broad-based advanced knowledge 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
• Ability to manage competing priorities in a fast paced environment
• Represents leadership on projects within multiple areas, interfacing with project managers, regulatory affairs team and middle management
• Consult in project setting within multiple regulatory affairs areas, interfacing with low to middle management
• Provides regulatory affairs leadership to outsourcing partners on a task level, participates 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 15,000 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.