Principal Regulatory Affairs Specialist (Remote)
Company: Medtronic GmbH
Location: Mountain View
Posted on: April 4, 2021
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Job Description:
Principal Regulatory Affairs Specialist (Remote) The Principal
Regulatory Affairs Specialist will play a key role in launching new
products and sustaining the current product portfolio. As a new
product development (NPD) core team member, the principal
specialist works directly with the NPD team from the concept phase
through commercialization. The principal specialist has primary
responsibility for compliance with US and EU regulatory
requirements and partners with the international regulatory affairs
group to support regulatory submissions worldwide for
electrosurgical devices (e.g., generators, vessel sealing devices).
Sustaining regulatory responsibilities include reviewing product
labeling changes to ensure that regulatory requirements continue to
be met, documenting "no file" decisions, reviewing promotional
materials, and ensuring that our product technical documentation is
current and accurate. This position is most suited for individuals
with a broad background covering the total regulatory life cycle of
medical devices and strong working knowledge and experience with
reviewing advertising and promotional materials for medical
devices. A Day in the Life
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) A commitment to our employees lives at the core of our
values. We recognize their contributions. They share in the success
they help to create. We offer a wide range of benefits, resources,
and competitive compensation plans designed to support you at every
career and life stage. This position is eligible for a short-term
incentive plan. Learn more about Annual Salary and Medtronic
Incentive Plan (MIP) on Page 6 here . 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, Mountain View , Principal Regulatory Affairs Specialist (Remote), Other , Mountain View, California
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