Edwards Lifesciences Senior Manager, Regulatory Affairs - Advanced Technology in Irvine, California
The Senior Manager, Regulatory Affairs within Edwards' Advanced Technology division focuses on next generation cardiovascular implantable devices and accessories. The initial focus will be on proof of concept building to full commercialization globally with the key areas of focus being Class III implantable and patient management/monitoring systems.
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:
A Bachelor's Degree in a scientific discipline is required and a minimum of 12 years of regulatory affairs experience is required
A Master's Degree or equivalent in a scientific discipline is preferred
Experience preparing domestic and international product submissions for medical device products is required
Coursework, seminars, and/or other formal government and/or trade association training 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 the 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 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.