Job Information
Medtronic Regulatory Affairs Manager – Peripheral Vascular Health (hybrid) in Plymouth, Minnesota
Regulatory Affairs Manager – Peripheral Vascular Health (hybrid)
Imagine seeing yourself in a role that will change what it means to live with Peripheral Vascular Disease. Come be a part of Medtronic’s fast-growing Peripheral Vascular Health business. We are looking to hire a Regulatory Affairs Manager for this dynamic and growing business. 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.
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 Here (https://www.medtronic.com/us-en/about/careers/diversity-inclusion.html)
Careers That Change Lives:
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 products and therapies and maintain existing products to global markets.
A Day in the Life:
Specific responsibilities include the following:
Oversee team’s area of product responsibility, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports
Provide input and direction to peripheral products 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
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelor’s Degree
Minimum 5 years experience in regulatory affairs for Class II and Class III medical devices
Or advanced degree and a minimum 3 years experience in regulatory affairs for Class II and Class III medical devices
Nice to Have (Preferred Qualifications):
Minimum 7 years experience in regulatory affairs for Class II and Class III medical devices, or advanced degree and a minimum 5 years experience in regulatory affairs for Class II and Class III medical devices
Degree in a scientific/ engineering discipline
Proven expertise in regulatory affairs, including, strategy planning, submission preparation, all phases of US FDA and EU MDR regulations, global regulatory requirements and procedures, negotiations, product design and development systems
Combination device experience
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 10%
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, recruiter 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 here (http://benefits.medtronic.com/) .
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .
The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
Min Salary
114400
Max Salary
171000
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.