Director of Regulatory Affairs -Forecasted Opening
Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: April 8, 2021
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Job Description:
We have made changes to enhance your experience. If you have
applied for a job previously, you will need to create a new
account. Thank you for your patience. Director of Regulatory
Affairs -Forecasted Opening USA - California - Irvine Manage
Regulatory Affairs team and activities within the respective
country(ies).
Key Responsibilities:
--- Direct activities through several managers, with overall
responsibility of developing systems, planning, staffing,
budgeting, managing expense priorities, recommending and
implementing changes to methods. Develop a robust talent
development and succession planning in alignment with functional
growth strategies across regional regulatory affairs
--- Plan and direct strategic activities including prioritizing and
selecting appropriate projects with overall responsibility for
meeting business objectives. Lead in identifying risk, developing
complex mitigation strategies, best practices, alternative
solutions, resolving issues, etc. in collaboration with cross
functional and/or matrix teams
--- Mitigate/eliminate risk, direct and communicate highly complex
regional regulatory affairs strategies which includes negotiations
with internal and external parties
--- Analyze, formulate and present recommendations related to
regional regulatory affairs to advise and guide executive level
leadership; develop and deliver executive level communication
--- Other incidental duties
Education and Experience:
Bachelor's Degree in in related fieldrelated experience in
lifesciences Required
Master's Degree or equivalent in in related field Preferred
Other: skill levels exceeding the requirements of the Senior
Manager Required and
Other: Demonstrated track record in people managemen Required
and
Other: Experience working in a healthcare company, regulatory
affairs and medical device Required
Additional Skills:
--- Proven successful project management leadership skills
--- Proven expertise in Microsoft Office Suite and related tools
and government regulatory systems
--- Excellent problem-solving, organizational, analytical and
critical thinking skills including high discretion/judgment in
decision making
--- Excellent written and verbal communication skills and
interpersonal relationship skills including negotiating and
relationship management skills with ability to drive achievement of
objectives
--- Excellent influencing and presentation skills
--- Fluent in reading, writing and speaking English
--- Expert understanding of regulatory affairs procedures while
looking beyond existing methodologies and own discipline to define
and resolve complex problems
--- Expert understanding of related aspects of regulatory affairs
processes and/or systems
--- High level of knowledge of financial mechanism that relates to
regulatory affairs
--- Demonstrated ability to direct teams and provide coaching and
feedback, including responsibility for all employee actions
including hire/fire authority and partnering with HR on all aspects
of employee relations
--- Ability to develop and integrate metrics into the projects and
operations that clearly demonstrate the value of regulatory affairs
to the business
--- Serve as core partner to senior leaders in Business Units,
Functional Groups, Regions and IT
--- 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 work and excel within a fast paced, dynamic, and
constantly changing work environment
--- Interacts with senior management, and others concerning matters
of significance to the company
--- Conduct business and technical briefings for senior and top
management and for external representatives
--- Regularly interacts with executives and/or major customers;
interactions frequently involve special skills, such as negotiating
with customers or management or attempting to influence senior
level leaders regarding matters of significance to the
organization
--- Dedicated to quality client service and pro-active and
responsive to client needs.
--- Develop peer, cross functional and cross business relationships
to maximize best practice sharing and team effectiveness.
--- Provide leadership and direction to large cross-functional
teams to successfully implement global enterprise systems and
related solutions
--- Develop relationships and leverage them to influence change
--- Support and solicit input from team members at all levels
within the organization 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
Travel Requirements:
40% % required E dwards is an Equal Opportunity/Affirmative Action
employer including protected Veterans and individuals with
disabilities. Posted 30+ Days Ago Full time Req-5522 About Us
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.
Keywords: Edwards Lifesciences Gruppe, Irvine , Director of Regulatory Affairs -Forecasted Opening, Executive , Irvine, California
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