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Sr Manager, Regulatory Affairs (Irvine, CA)

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: September 17, 2022

Job Description:

Sr Manager, Regulatory Affairs (Irvine, CA), Critical Care: People Leadership role with a project scope for products in sustaining stagesLocation:Edwards Lifesciences Corporate Headquarters in Irvine, CaliforniaThis is an exciting opportunity to provides expertise, leadership, and guidance for a team within our Regulatory Affairs, Critical Care business unit. This role seeks to lead, strategize, advance and optimize processes for sustaining tasks and continue ensuring safety and effectiveness for commercialized products within assigned areas, by ensuring compliance with global regulations.Key Responsibilities:

  • Manage and oversee the work of team within country regulatory affairs and may indirectly manage cross functional or matrix teams as appropriate
  • Develop a robust talent development plan in alignment with functional growth strategies of the department
  • Manage activities with the accountability for successful completion of all deliverables
  • Plan registration, labeling, pricing and reimbursement activities within agreed timeline in order to deliver licenses and to ensure regulatory compliance and market access
  • Develop in-country annual strategy on new product introduction pipeline and R&D budget forecast and management
  • Identify risk, develop and lead in the implementation of registration and labeling strategies which may include negotiations with internal and external parties
  • Other incidental dutiesEducation and Experience:
    • Minimum of Bachelor's Degree in related engineering or scientific discipline required
    • Related professional experience in Regulatory Affairs Required
    • Demonstrated track record in people management Required
    • Experience working in a medical device, pharmaceutical or RA company RequiredAdditional Skills:
      • Proven successful project management leadership skills
      • Proven expertise in both Microsoft Office Suite 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
      • Good presentation skills
      • Excellent English skill
      • Expert understanding of regulatory affairs procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
      • Expert understanding of related aspects of product lifecycle processes, Edwards Ignite system (or similar) and government regulatory systems
      • Knowledge of global cross functional teams and how to interact e.g. labeling business units, marketing, regulatory affairs, quality functions
      • Knowledge of financial mechanism that relates to budget forecast and profit & loss
      • Demonstrated ability to manage assigned team 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
      • Extensive knowledge of Edwards products
      • Knowledge of healthcare industry
      • 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
      • Frequently interacts with customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team
      • Participate and present at meetings with internal and external representatives
      • Resolve operational and scheduling issues
      • 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
      • Develop relationships and leverage them to influence change
      • Support and solicit input from team members at all levels within the organization
      • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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/controlEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. - As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. - If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated. -

Keywords: Edwards Lifesciences Gruppe, Irvine , Sr Manager, Regulatory Affairs (Irvine, CA), Executive , Irvine, California

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