Regulatory Affairs Manager

Careers That Change Lives:Imagine playing a role in changing what it means to live with Aortic Stenosis. Come be a part of Medtronic's fast-growing Structural Heart business. We are looking to hire a Regulatory Affairs Manager for this dynamic, high visibility transcatheter aortic valve (TAVI) therapy in Structural Heart. In the Regulatory Affairs team, we focus on harnessing our collective strength to deliver best-in-class solutions that benefit patients and our cross functional partners.The Regulatory Affairs Manager is responsible for leading a team of Regulatory professionals with responsibility for developing strategies and executing on regulatory submissions to introduce new TAVI products (Class III) and labeling indication expansion changes to global markets.We believe that when people from different cultures, genders, and points of view come together, innovation is the result - and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. To learn more about Inclusion & Diversity at Medtronic Click HereA Day in the Life:Specific responsibilities include the following: Oversee team's area of responsibility, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports Provide input and direction to TAVI ME Core Team in development and execution of market expansion opportunities Provide direction, leadership and coaching to staff to meet schedules, resolve technical or operational problems Direct interaction with regulatory agencies on defined matters. Keeps abreast of regulatory procedures and changes. Participate in audits and be part of field action teams Accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives. Recruit, develop and retain talent.Must Have (Minimum Requirements): Bachelor's Degree and a minimum 5 years' project / people management experience in regulatory affairs for medical devices, OR advanced degree and a minimum 3 years' project / people management experience in regulatory affairs for medical devicesNice to Have (Preferred Qualifications): Advanced degree in a scientific/ engineering discipline Proven expertise in regulatory affairs, including, strategy planning, submission preparation, all phases of FDA regulations, global regulatory requirements and procedures, negotiations, product design and development systems Experience interfacing with regulatory agencies Highly motivated and results-oriented leader Demonstrated supervisory and interpersonal skills Ability to flex and adapt to changing priorities Ability to handle advanced concepts and undefined paths Effective project management skills and experience Effective oral and written communication skills Ability to travel approximately 20%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)