Edwards Lifesciences is the global leader in hemodynamic monitoring. The Director, Regulatory Affairs will play a key role in expanding our regulatory support and strategy across our revamped Critical Care business 24 large and expanding. Under new leadership, Critical Care has rebuilt a team that has consistently been profitable with multiple new products in the pipeline. With multiple recent successful launches of both innovative new products and updates to existing technologies, this team is growing with the promise of new and exciting projects in the US and globally.
This Director will report to the VP and will be responsible for building a team to lead and execute on global regulatory strategies, direct complex project interactions, and ensure the organization is ready for the impending European Medical Device Regulation and other emerging issues. The role includes opportunities to be responsible for the preparation of submissions, including IDEs, 510(k)s, PMAs, and design dossiers and technical files for CE marking, as well as obtain and maintain approvals for the commercial distribution of products worldwide. Additionally, this role will ensure appropriate maintenance and compliance to corporate standard operating procedures and industry standards. This leader will build relationships with Edwards’ Critical Care leaders and respective organizations, and be a catalyst in delivering solutions to support the needs of the organization and overall business objectives.
Key responsibilities of this position include:
Negotiate and communicate effectively, both internally and externally, with cross-functional project teams, management, regulatory agencies (i.e. FDA, TUV, CFDA, PMDA etc) and business partners to ensure objectives of programs are met on time.
Ensure maintenance of compliance associated with CE mark and technical files.
Organize project and departmental objectives and delegate effectively.
Educate internal and external customers regarding regulatory requirements.
Lead Regulatory Affairs staff and directly participate on project teams.
Bachelor's degree in nursing, science or engineering is required.
Advanced degree in the sciences, Ph.D., or a combination of an MBA or J.D. with a science degree is highly desirable.
Background should include extensive experience and knowledge of global regulatory requirements for cardiovascular medical devices, including surgical and interventional devices products, technologies and markets; and a successful regulatory track record in the commercialization of innovative, complex medical devices (i.e. 510k, IDE/PMA and Class II or III CE approvals).
Relevant experience may include: Class II and Class III medical devices, software, algorithms, predictive analytics, monitoring devices, catheters, infusion pumps, and/or ICU monitors.
Knowledge of IEC 60601 and software submissions is preferred.
A documented and recognized track record of bringing new products to market in the medical device industry with a strong preference toward the Critical Care monitoring or diagnostics market.
Possess the ability to communicate effectively with both customers and industry thought leaders.
Demonstrate a sense of urgency; understand the importance of outperforming and outpacing the competition in meeting customer and patient needs.
Good conceptual, analytical, problem solving, and organizational skills.
Be a “hands-on” individual who enjoys challenge, is capable and dedicated to getting the job done with minimal support and direction.
Be an assertive, take-charge, proven manager with a strong results orientation, a positive attitude, and a sense of urgency. Must have a strong sense of individual accountability and also be able to work well in a team environment.
Ability to build, motivate and manage a strong regulatory organization, continuously developing the talents of the team to achieve high performance for current and future business needs.
Well-organized and accustomed to maintaining excellent records.
Be able to travel up to 20% of time, as needed.
Internal Number: 013912
About Edwards Lifesciences
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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.