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Regulatory Affairs Program Manager

Employer
Medtronic
Location
Saint Paul
Salary
Competitive

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REGULATORY AFFAIRS PROGRAM MANAGER The Cardiac Ablation Solutions (CAS) division is focused on disrupting the Electrophysiology (EP) market to be the number one arrhythmia care pathway, cardiac mapping and ablation solutions provider for our customers and patients. Inspired by the Medtronic mission and dedicated to transforming the lives of people with cardiac arrhythmias, to date CAS has transformed the lives of almost 1 million patients. Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident -we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions. Careers that Change Lives Reporting to the Senior Director the Program Manager will establish and maintain a consistent Project Management framework needed to successfully develop and track global strategies and critical compliance activities such as product renewals and registrations, changes that impact global registrations and global expansion of CAS portfolio. Partner with Operating Unit and International Regulatory Affairs staff to create and maintain dashboards for geographies to drive alignment on global regulatory priorities and maintain relevant metrics using data analytics. A Day In The Life Create and maintain a tracking and planning system for critical compliance activities, including global product renewals and registrations, product/system changes that impact global registrations and global expansion of CAS portfolio to aid teams in resource planning and implementation. Partner with Operating Unit and International Regulatory Affairs staff to develop and execute global regulatory strategies for the expansion of new and existing products. Partner with Operating Unit and International Regulatory Affairs staff to create and maintain dashboards for geographies to drive alignment on global regulatory priorities Work with Operating Unit Regulatory management and staff to determine, track and communicate key Regulatory metrics leveraging data analytics and visual management techniques. Define and report metrics (scorecards) on program progress, implementation and effectiveness; deliver management reporting and escalation when required Coordinate with cross-functional teams, including regulatory, quality and clinical functions to finance, R and operations Monitor progress toward objectives, assesses risk and implement strategies to ensure successful project completion that align with organizational goals. Work with functional team members to ensure clear communication of project/program objectives, deliverables, and timing of key milestones. Must Have (minimum requirements) Bachelor's degree Minimum of 5 years of Program Manager experience within medical device or other regulated industry, or advanced degree with a minimum of 3 years of Program Manager experience. Desired/Preferred Qualifications Medical device industry experience Regulatory Affairs experience Analytical, process and data visualization experience Working knowledge of Project Management methodologies and tools; PMP certification is an asset. Experience with tracking software tools (e.g. Power BI or others) Demonstrated strong business acumen and planning. Strong communication skills (written, verbal, listening) with all levels of the organization. Strong interpersonal, quantitative analysis, and problem-solving skills. High degree of initiative and influence management skills Ability to facilitate team meetings, creates and delivers presentations, and drive meetings to action-oriented decisions. Experience working in a virtual team environment in supporting cross-functional teams remotely. Results oriented. Ability to drive to completion in adherence to aggressive project schedules. About MedtronicTogether, 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. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe 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: benefits.medtronic.com This position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here .

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