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Regulatory Labeling Manager

Company: Medtronic GmbH
Location: Irvine
Posted on: February 23, 2021

Job Description:

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future. Careers That Change Lives As the Regulatory Labeling Manager, you will be responsible for managing product labeling projects supporting multiple labeling projects throughout the product lifecycle. A Day In The Life

  • Manage complex labeling-related projects, schedules, milestones, inter-dependencies, deliverables, and resources
  • Oversee labeling project teams and activities to meet business plan and quality requirements
  • Act as a point of contact for, and liaison to, functional and project managers for labeling planning, strategy, development, logistics, interdependencies, quality, etc.
  • Work with management and functional groups to ensure use of standard business processes and procedures to support compliance with federal and international regulations and industry standards.
  • Provide direction to technical writers within your project team.
  • Participate, or ensure team participation on, high-level product development team(s).
  • Coordinate/manage labeling project team work with all related functional groups and outside contractors and suppliers. Proactively communicate labeling interdependencies to project and project managers.
  • Serve as key communications contact with management to provide information and status on schedules, milestones, deliverables, etc., and to identify resource issues and needs.
  • Ensure labeling deliverables are on schedule.
  • Partner with Medtronic Translations to prioritize translation projects across projects, monitor translation progress, and communicate translation status to project and project managers. Partner with technical writers to develop project language strategy and partner with functional management to comply with new local language requirements.
  • Estimate labeling resource needs for individual projects and communicate to functional management during annual operation planning
  • Support key cross-functional and cross-business unit partnerships.
  • Partner with technical writing team to develop, communicate, and execute a labeling strategy for projects and projects. Seek input from a variety of functional areas and stakeholders on labeling project strategy.
  • Provide input on department process and practice efficiencies and internal department initiatives.
  • Occasionally own labeling CAPAs from investigation through closure.
  • Partner with technical writers to identify design inputs and create labeling product requirements. Must Have; Minimum Requirements
    • Bachelors Degree required
    • Minimum--5--years of regulatory project management experience; or a minimum 3 years of regulatory project management experience with an advanced degree. Nice To Have
      • Experience managing complex projects or projects, especially electronic products, labeling, medical devices or pharmaceuticals
      • Experience leading projects to completion
      • Excellent people and communication skills (verbal and written)
      • Strong organizational skills
      • Technical Writing experience in a regulated environment
      • Experience interacting with a broad range of functional groups and individuals at various levels of the organization
      • Experience managing multiple projects successfully
      • Experience using electronic tools for managing projects, routing reviews and approvals, allocating resources, etc.
      • 5+ years of experience in cross-functional, cross-geography project management
      • 5+ years of experience in a labeling creation environment
      • Experience working with cross-geography projects and teams
      • Experience working on projects requiring localization/translation
        About Medtronic


        Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

        We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

        Physical Job Requirements

        The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America) It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here .

Keywords: Medtronic GmbH, Irvine , Regulatory Labeling Manager, Executive , Irvine, California

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