Medtronic
Senior Principal Regulatory Affairs Specialist (hybrid) (Finance)
A Day in the Life
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 over 1 million patients.
Preference is for this position to be based in Mounds View, MN but a remote worksite may be considered.
The Senior Principal Regulatory Affairs will play a key role in providing regulatory affairs support for Class I, II and Class III medical devices. The Sr Principal Regulatory Affairs Specialist is responsible for activities to launching new products and sustain the current regulatory activities that lead to and maintain regulatory approval for medical devices primarily associated with ablation therapy that supports the diagnosis and treatment of atrial fibrillation. The Sr Principal Regulatory Affairs Specialist will work directly with development and sustaining teams to support regulatory activities throughout the product lifecycle. The Sr Principal Specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs specialist and in country specialists as needed, to support regulatory submissions worldwide for Class I, II, and Class III medical devices. Activities will include careful and clear documentation of regulatory decisions, authoring well written submissions to agencies, reviewing promotional materials, and ensuring that product technical documentation is current and accurate. Responsibilities are performed through the collaboration with various functions across the Operating Unit, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, Operations, Global Supply Chain and Marketing and externally with regulatory bodies in the US, EU and other agencies as needed.
Responsibilities also include keeping senior management informed of the regulatory status of products and significant regulatory issues while continuously maintaining proficiency in global regulatory requirements.
The successful candidate will be able to deal with advanced concepts and undefined paths, work independently, develop new regulatory strategies and solutions based on experience and work collaboratively within the Regulatory department and other business functions. This position reports to the Senior Regulatory Affairs Manager.
Role And Responsibilities:
Must-Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Preferred experience:
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
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.
Salary ranges for U.S (excl. PR) locations (USD):$152,000.00 - $228,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here .
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.
At Medtronic, most positions are posted on our career site for 3-7 days.