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Regulatory Affairs Program Manager (remote)

Boulder, CO 80305 Work Remotely
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Regulatory Affairs Program Manager (remote)


Boulder, Colorado, United States

Requisition #:


Post Date:

Feb 10, 2021


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.

**Careers That Change Lives**

The **Regulatory Program Manager** will translate regulatory and strategic business requirements into project/product requirements, manage documentation timelines, support the preparation of regulatory submissions, all while ensuring timely and high-quality execution of all support functions.

This role focuses on program management support for the EU MDR regulation, with a wide variety of program management tasks to allow you to make the most of your existing knowledge base while growing your management skill set every day. In this role, you will have primary program management responsibility for multiple Class II and Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.

This role is an excellent opportunity for the right program management professional to take their career to the next level at the worlds leading medical device company. The Regulatory Program Manager will work alongside the Regulatory Managers to provide direction and leadership to a cross-functional team , business group / business unit and site PMO leaders and representatives, and functional leaders. The position requires the ability to drive strategic activities while also managing tactical activities and communicating effectively with a large group of stakeholders. The Regulatory Program Manager is responsible for ensuring team commitments (scope, schedule and budget) are met and communicated in a timely manner.

This role has great leadership development opportunities as it operates across the BUs and functions and has the opportunity to influence decision and actions at all leadership levels of Medtronic.

**A Day In The Life**

+ Responsible for achieving successful implementation of governmental regulations while ensuring best-in-class practices as a competitive advantage for the business.

+ Focused on delivering critical world class technologies related to lung health, visualization, hernia, wound management.

+ Leads the program under the direction of a Cross Functional Steering Committee and provides program management structure to work-stream teams working on regulation assessment and implementation.

+ Directs day to day activities for multiple work-stream teams through managing project plans, resourcing, status reporting, resolving issues, identifying project risks and accountability for deliverables across multiple functional organizations.

+ Establishes meaningful metrics.

+ Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost.

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 5 yearsexperience,in medical device regulatory affairs or advanced degree with a minimum of 3 years of experience in medical device regulatory affairs

**Nice to Have**

+ Engineering or similar technical degree

+ Masters in Regulatory Affairs or RAC

+ Demonstrated project/program management experience

+ Successful track record of regulatory submittals

**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)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Learn more about our benefits:

This position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here
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: 2021-02-12 Expires: 2021-04-23
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Boulder, CO 80305

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