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Mounds View, MN 55112
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Mounds View, Minnesota, United States

Requisition #:


Post Date:

Oct 25, 2021

**REGULATORY AFFAIRS SPECIALIST (Defibrillation Solutions)**

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is composed of four key businesses: Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

**C** **areers That Change Lives**

The **Regulatory Affairs Specialist** will provide regulatory affairs support for CRM Defibrillation Solutions medical devices. The Regulatory Affairs Specialist is also responsible for sustaining activities including: maintain regulatory approvals and provide assessment of device changes for regulatory implications.

**A Day In The Life**

+ Develop proficiency in worldwide regulatory requirements.

+ Write and coordinate regulatory submissions

+ Interface with governmental agency on projects/products as identified by the manager.

+ Assist with maintenance of Regulatory Affairs product files to support compliance with regulatory requirements.

+ Provide regulatory input for product development and manufacturing, including review of specifications, protocols and reports, engineering change notices, nonconforming materials, product complaints, and product failure analysis

**Must Have: Minimum Requirements**

+ Bachelors degree required

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

**Must Have; Minimum Requirements**

+ Bachelors Degree

+ Minimum 2 years medical device regulatory experience

+ OrAdvanced degree with 0 years of experience

**Nice To Have**

+ Degree in Engineering, Regulatory Science, Life Sciences or related medical/scientific field preferred

+ Possess experience or coursework in regulation of medical devices or experience working with medical devices.

+ Submissions related word processing skills

+ Experience with medical devices

+ Some regulatory/product development/ clinical experience

+ 5 years industry experience

+ Strong written/oral communication skills

+ Strong organizational and time management skills

+ Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines

**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.


Posted: 2022-03-08 Expires: 2022-06-06
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