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9 days old

Regulatory Affairs Specialist

Medtronic
Seoul
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Regulatory Affairs Specialist

Location:

Seoul, Seoul, Korea

Requisition #:

19000GAD

Post Date:

Sep 05, 2019

**Careers that Change Lives**


**A Day in the life**


Responsibilities may include the following and other duties may be assigned


+ Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

+ Leads or compiles all materials required in submissions, license renewal and annual registrations.

+ Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

+ Monitors and improves tracking / control systems.

+ Keeps abreast of regulatory procedures and changes.

+ May direct interaction with regulatory agencies on defined matters.

+ Recommends strategies for earliest possible approvals of clinical trials applications.


**SPECIALIST CAREER STREAM:**


+ Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.


**DIFFERENTIATING FACTORS:**


+ **Autonomy:** Customer responsive, competitive and market driven, leads and supports Change

+ **Organizational Impact:** Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to thecompletion of project milestones . May have some involvement in cross functional assignments.

+ **Innovation and Complexity:** Problems and issues faced are general, and may require understanding of broader set of issues orother job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes tosolve problems or improve effectiveness of job area.

+ **Communication and Influence:** Communicates primarily and frequently with internal contacts . External interactions are lesscomplex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gaininput, and support decision-making.

+ **Leadership and Talent Management:** May provide guidance and assistance to entry level professionals and / or employee inSupport Career Stream.


**Must Have: Minimum Requirements**


+ Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

+ Bachelor's Degree Required


**Additional Requirements**


Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a Baccalaureate degree (or for degrees earned
outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A) and minimum of 2 years
of relevant experience, or advanced degree with 0 years of experience.


**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. Lets 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)


For employees working in Quebec, Canada only: Basic knowledge of French is required. - (Quebec-Canada)
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.

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Posted: 2019-09-10 Expires: 2019-10-18
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Regulatory Affairs Specialist

Medtronic
Seoul

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