Regulatory Affairs Program Manager - Peripheral Vascular Health

REGULATORY AFFAIRS PROGRAM MANAGER - Peripheral Vascular Health (remote)

Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. We lead the way in the Superficial Venous and Drug Coated Balloon markets, caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies.

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:

In this role, you will be responsible for establishing and maintaining a strong training program (on -boarding, enhancing Regulatory competencies, audit readiness, product, therapy and functional expertise) for the PVH Regulatory Department in addition to driving critical compliance activities. This individual will drive continual improvement within the function through active engagement across PVH RA and development of ideas and processes to drive efficiencies in Regulatory activities. Additionally, this individual is expected to play a key role in the mentoring of more junior team members and be an active participant in the development and training of the Regulatory Affairs team. The individual will work in collaboration with Regulatory Affairs team members, cross functional members of the Operating Unit at many levels within the organization as well as global staff to ensure continuous improvements in the training program. The Regulatory Affairs Program Manager reports to the Regulatory Solutions Director.

A Day In The Life

• Work with Operating Unit Regulatory management and staff to build and/or increase Regulatory knowledge base across department through robust RA training modules
• Incorporate product training, clinical/therapy training, audit training and operations training into the Regulatory training curriculum
• Coach more junior RA staff across a variety of activities
• Engage and actively participate in compliance preparation and execution activities
• Actively seek out opportunities for efficiencies and simplification. Engage with RA staff to drive continuous improvement activities
• Partner in real-time problem resolution in an effort to mitigate functional/ program level challenges to keep objectives moving in line with program estimates
• Work with Operating Unit Regulatory management to determine and optimize required Cornerstone training for Regulatory Department
• Determine and track Regulatory procedure revisions and training
• Work within a matrixed, collaborative team environment that fosters professional development while focusing on meeting business objectives driven by standards of excellence.

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 medical device or other regulated industry

Nice To Have

• Direct medical device Regulatory Affairs experience supporting programs throughout product development lifecycles
• Passion for training and mentoring others
• Audit experience
• 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, create and deliver 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 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. Let's 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: 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 .