At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

In the Neurovascular Operating Unit, we are committed to delivering meaningful innovation to advance stroke treatment. You can view more about the business and our products at https://www.medtronic.com/us-en/e/neurovascular.html .

Our goal as an operating unit is to ensure that we utilize the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career.

Join a diverse team of innovators who bring their worldview, unique backgrounds, and individual life experiences to work daily. 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 medical technology and solutions leader.

The Senior Regulatory Affairs Specialist will be vital in launching new products and sustaining the current product portfolio. The senior specialist complies with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining regulatory responsibilities include reviewing changes to ensure that regulatory requirements continue to be met, documenting "no file" decisions, reviewing promotional materials, and ensuring that our product technical documentation is current and accurate.

Responsibilities may include the following and other duties may be assigned.

• Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications.


• Prepare Pre-Sub, IDE/IDE Supplement, PMA Supplement, and technical documents to support CE mark/MDR submissions.


• Manage multiple projects and prioritize tasks to meet project schedules


• Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities


• Communicated with regulatory agencies and notified bodies and served as a regulatory liaison for the project team throughout the product lifecycle.


• Review promotional and advertising material.


• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards.


• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements.


• Participate in internal and external audits as needed


• Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements


• Perform other duties as assigned or required

Required Knowledge and Experience:
Requires a Baccalaureate degree

Minimum of 4 years of medical device regulatory affairs experience or advanced degree with a minimum of 2 years experience.

Nice To Have

• D egree in Science or Engineering


• RAPS Professional Certification (RAC)


• History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.


• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards


• Ability to manage multiple projects and proficiency with Microsoft Office and software tools.

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):$88,800.00 - $133,200.00

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.