Regulatory Affairs Specialist - Electrophysiology Therapies

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

The Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S, EU, and global submissions, and obtaining and maintaining approval for Electrophysiology (EP) Therapies 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 EP Therapies Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It includes 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.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do.

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.

Come for a job, stay for a career!

A Day in The Life:

• •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, with a focus on the Cardiac Pacing Therapies and Defibrillation Solutions product portfolio at Medtronic’s Galway, Ireland facility. Work with engineers and technical experts to address questions from regulatory agencies.
• •Provide support to currently marketed products. This includes reviewing labelling, 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.
• •Support product development programs as an extended core team member.
• •Assist in negotiations with the FDA, Notified Bodies, or other regulatory agencies for assigned projects.
• •Other tasks as assigned.

Key Skills & Experience

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):

• •Working with Class II/III medical devices and 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 with strong interpersonal, organizational and time management skills

Medtronic offer a competitive salary and flexible Benefits Package

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.

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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.

Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 48,400.00 EUR - 72,600.00 EUR |

The final salary within this range will be determined based on objective, job-related criteria, including relevant experience, skills and qualifications, in accordance with our compensation framework. ‌

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).