REGULATORY AFFAIRS PROGRAM MANAGER - Coronary and Renal Denervation (remote)
The Coronary and Renal Denervation (CRDN) division is focused on therapies that are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI). We also are leading the way with the transformational renal denervation therapy, which has the potential to be a powerful tool in battling the global hypertension epidemic. 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 Regulatory Affairs Professionals who bring their knowledge, 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 Director, the Program Manager will support Research and Development programs through pre-market Regulatory strategy development while providing strategic guidance to more junior members of the team. The individual will establish and maintain a consistent Project Management framework needed to successfully manage critical compliance activities such as product renewals and registrations, audits, and changes that impact global registrations. The Program Manager will drive continual improvement within the function through the active engagement and development of ideas to drive efficiencies in Regulatory activities. Additionally, the Program Manager is expected to play a key role in the mentoring of more junior team members and be an active participate 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 International Regulatory Affairs staff. Strategic direction is provided supporting a number of regulatory applications including original IDEs and PMAs, IDE and PMA supplements/Reports, FDA Pre-submissions, Shonin applications, NMPA registrations, Canadian Medical Device License Applications and EU MDR Design Dossiers.
A Day In The Life
* Engage and actively participate in compliance preparation and execution activities including identification of opportunities for improved efficiencies.
* Partner with Operating Unit cross functional partners and International Regulatory Affairs staff to develop and execute global regulatory strategies for the expansion of new and existing products.
* Work with Operating Unit Regulatory management and staff to build and/ or increase knowledge base in new areas of opportunity for new product development
* Coordinate with cross-functional teams, including regulatory, quality, marketing and clinical functions to finance, R&D and operations
* Work with functional team members to ensure clear communication of project/program objectives, deliverables, and timing of key milestones.
* Provide strategic direction for regulatory filings while actively mentoring team members in the development of regulatory strategies to support regulatory approvals for new and existing products.
* Partner in problem resolution in an effort to mitigate functional/ program level challenges to keep objectives moving in line with program estimates
* Working 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
* Direct medical device Regulatory Affairs experience supporting programs throughout product development lifecycles
* Analytical, process and data visualization experience
* Working knowledge of Project Management methodologies and tools; PMP certification is an asset.
* 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.
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.