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1+ months

Sr Principal Compliance/Audit Specialist

Medtronic
Fridley, MN 55432 Work Remotely
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Sr Principal Compliance/Audit Specialist

Location:

United States

Requisition #:

220003GN

Post Date:

Feb 14, 2022


**Careers That Change Lives**


A career at Medtronic is like no other. Were purposeful. Were committed. And were driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.


In this exciting role as a **Sr Principal Compliance/Audit Specialist** you will have responsibility to identify trends, coach and mentor, share knowledge, develop improvement strategies and conduct and report on internal assessments of Medtronic facilities worldwide to determine the state of compliance to appropriate regulations and standards, corporate policies and expectations.


**A Day in the Life**


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


+ Coordinates and/or completes internal/external risk assessments and/or audits/assessments and compliance in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.

+ Manages and oversees internal audit/assessment activities, which may include conducting and/or overseeing audits/assessment, investigations, and/or interviews; and preparing corresponding reports and documents.

+ Interprets and implements applicable regulations as they apply to products, processes, practices and procedures.

+ May counsel stakeholders about these requirements as necessary.

+ Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.

+ Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.

+ Develops and implements improvement strategies, programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.

+ May represent audit function during external regulatory authority activity.

+ Ensures connection with industry, with areas of focus, trends, themes externally.

+ May coach and mentor internal auditors and stakeholders.


**Must Have: Minimum Requirements**


**To be considered for this role, please ensure the minimum requirements are evident on your resume.**


Bachelorsdegree with 10+ years of work experience in Quality or regulated industry OR Advanced degree with 8+years of work experience in Quality or regulated industry.


**Nice to Have**


+ Prior FDA or NB auditor experience

+ Experience with FDA Quality System Inspection Technique

+ Experience in Quality/Compliance and/or Audit with medical device requirements (e.g. MDSAP, EU MDR, ISO 13485)

+ Experience auditing Quality Systems to global requirements

+ Quality System Lead Auditor certified

+ Specialized expertise (design controls, medical device software, robotics, acquisition activity)

+ Industry knowledge, ability to analyze information to identify trends and underlying issues


**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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Posted: 2022-03-08 Expires: 2022-06-12
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Sr Principal Compliance/Audit Specialist

Medtronic
Fridley, MN 55432

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