We anticipate the application window for this opening will close on - 30 Jun 2025

 

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

The Sr Regulatory Affairs Specialist will play a key role in sustaining the current product portfolio. The Sr Specialist has responsibility for compliance 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, submitting product changes and annual reports, and ensuring that our product technical documentation is current and accurate.

SENIOR REGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR 

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, their unique backgrounds, and their individual life experiences to work every day. 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 leader in medical technology and solutions.

Careers That Change Lives

The Sr Regulatory Affairs Specialist will play a key role in sustaining the current product portfolio.  The Sr Specialist has responsibility for compliance 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, submitting product changes and annual reports, and ensuring that our product technical documentation is current and accurate. 

 A Day In The Life

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

• Prepare Pre-Sub, IDE/IDE Supplement, PMA/PMA Supplement, 510(k) submissions 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

• Communicate with regulatory agencies and Notified Body and serve as regulatory liaison on 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

Qualifications - External

Must Have; Minimum Requirements

• Bachelor's degree in Science or Engineering (or related field) from an accredited college or university required.

• Minimum of 4 years of relevant experience

• Or advanced degree with a minimum of 2 years of experience in medical device regulatory affairs

This is not a remote position

 Nice To Have

• 4 years of experience in medical device regulatory affairs

• Excellent technical knowledge of medical products a