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

• Degree 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, an