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Regulatory Affairs Specialist


Mounds View, MN 55112
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Job Details

Regulatory Affairs Specialist


Mounds View, Minnesota, United States

Requisition #:


Post Date:

4 days ago


Cardiac Rhythm and Heart Failure (CRHF) offers devices and therapies to treat patients with abnormal heart rhythms and heart failure, as well as cardiac diagnostic and monitoring solutions.

**Careers That Change Lives**

The **Regulatory Affairs Specialist** is responsible for coordinating and preparing submissions related to our medical devices including clinical applications, initial product approval, changes to products and product renewals which may require direct interaction with regulatory agencies.

**A Day in the Life**

+ Coordinate and prepare product submissions for FDA and other major market regulatory agencies.

+ Provide support to market-released products as necessary. This includes reviewing labeling, promotional materials, product/manufacturing process changes and documentation for changes requiring government approval. Assist in the preparation of periodic reports for FDA and other major market regulatory agencies as required by product status. Submission decision/content will be approved by manager.

+ Develop and create regulatory strategies to ensure business goals are met.

+ Interface with governmental agency on projects/products as identified by the manager. Negotiate directly with FDA at the reviewer level, as directed by the manager.

+ Review advertising and promotion materials.

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

**Must Have; Minimum Requirements**

+ Bachelors Degree

+ Minimum 2 years medical device regulatory experience, or advanced degree with a minimum of 0 years medical device regulatory experience

**Nice to Have**

+ Masters Degree - Regulatory Affairs

+ PMA or 510(k) experience

+ Computer software applications including knowledge of Microsoft Office

+ Strong communication skills

+ Results oriented focus

+ Ability to work independently and support multiple projects

**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.
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