Regulatory Labeling Manager
Company: Medtronic GmbH
Posted on: February 23, 2021
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
- Provide direction to technical writers within your project
- 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
- 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
- Estimate labeling resource needs for individual projects and
communicate to functional management during annual operation
- Support key cross-functional and cross-business unit
- 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
- Partner with technical writers to identify design inputs and
create labeling product requirements. Must Have; Minimum
- 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
- Experience leading projects to completion
- Excellent people and communication skills (verbal and
- 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
- 5+ years of experience in a labeling creation environment
- Experience working with cross-geography projects and teams
- Experience working on projects requiring
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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