We anticipate the application window for this opening will close on - 10 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 Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and global submissions, and obtaining and maintaining approval for CRM products globally. Additionally, the Regulatory Affairs Specialist is responsible for assessing device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. 

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of three key businesses: Cardiac Pacing Therapies, Defibrillation Solutions, and Cardiac Diagnostic Services. Together, we will transform the lives of people with cardiac arrhythmias and heart failure.

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. To learn more about Inclusion & Diversity at Medtronic Click Here

Location: Mounds View, MN

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working onsite 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

A Day in the Life / Responsibilities:

• Collaborate with Operating Unit Regulatory Affairs Specialists and regulatory affairs specialists globally  to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to address questions from regulatory agencies.

• Provide support to currently marketed products as necessary. This includes reviewing labeling, product or process changes as well as supportive documentation for changes requiring regulatory agency review. Prepare submissions and reports for FDA or provide support and documentation for global submissions.

• Maintain proficiency in worldwide regulatory requirements. Obtain and distribute updated information regarding worldwide laws, guidelines, and standards. 

• Establish and maintain good relationships within the RA department, cross functional teams and assist in developing and maintaining positive relationships with device reviewers through oral and written communications.

• Support regulatory compliance activities, including internal or external audits, post-market surveillance activities, etc. as needed.

• Support product development programs as an extended core team member.

• Assist in negotiations with the FDA or other regulatory agencies for assigned projects.

• Other tasks, as assigned.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

• Bachelor’s degree required with a minimum of 2 years of experience in regulatory affairs in the medical device industry

Or

• Advanced degree with 0 years of experience

Nice to Have (Preferred Qualifications):

• Experience working with Class II/III medical devices

• Experience with regulatory support of clinical trials

• Experience with FDA requirements, guidance documents, Medical Device Directive (MDD), Medical Device Regulation (MDR), and/or other global regulatory requirements and quality standards.

• Effective negotiation and written/oral communication skills.

• Effective interpersonal, organizational and time management skills.

• Effective and respectful team member.

• Detail-oriented

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