13 days old

Regulatory Operations Spec

Medtronic
Hedgesville, WV 25427
Regulatory Operations Spec

Location:

Shanghai, China

Requisition #:

19000GRP

Post Date:

Sep 03, 2019


**Careers that Change Lives**


**A Day in the Life**


Responsibilities may include the following and other duties may be assigned.


+ Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of all submissions including initial large marketing authorization applications and electronic common technical documents (e-CTD).

+ Submissions are produced with electronic publishing tools in compliance with document management standards.

+ Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.

+ Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.

+ Prepares, submits, tracks, indexes and archives paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.


**Must Have: Minimum Requirements**


+ Bachelors degree required

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


**Nice to Have**


**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)
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.

Categories

Posted: 2019-09-05 Expires: 2019-10-12

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Regulatory Operations Spec

Medtronic
Hedgesville, WV 25427

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