Senior Regulatory Affairs Specialist

GAL Medtronic Vascular Galway Unlimited Company; Parkmore; On-site; EUR 64,000 - 96,000; Full time

Job summary

Medtronic plc in Galway, Ireland, seeks a Senior Regulatory Affairs Specialist to lead software-based medical device submissions (FDA eSTAR) and EU Notified Body processes. You will craft regulatory strategies, liaise with cross-functional teams, and ensure compliance across global markets.

The role requires experience in preparing submissions, regulatory planning, and maintaining product files, with a focus on IEC 62304 and life-cycle processes.

Qualifications

• Prepare US and EU MDR submissions for new products and product changes.
• Review significant regulatory issues with the Manager and partners and resolve submission issues.
• Prepare regulatory strategies and worldwide compliance requirements.
• Provide ongoing support to project teams on regulatory issues and questions.
• Provide regulatory information to support development of regulatory strategies and requirements.
• Provide regulatory support for currently marketed products and documentation.
• Prepare submissions/reports for regulatory agencies as required.
• Maintain Regulatory Affairs product files and stay current on directives and standards.

Responsibilities

• Prepare submissions for US/EU regulatory approvals and maintain timelines.
• Review issues with supervisor and coordinate with engineering/partners.
• Develop and communicate regulatory strategies and plans for product portfolios.
• Support project teams with regulatory questions and documentation.
• Coordinate with Marketing and Global Supply Chain on regulatory needs.
• Maintain regulatory files to ensure ongoing compliance.

Skills

US/EU submissions

regulatory strategy

international agencies

regulatory analysis

regulatory documentation

stakeholder collaboration

maintain regulatory files

Job description

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 Medtronic

At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Our Purpose

At our Regulatory Affairs department in Medtronic, plc, based in Galway, our mission is to develop innovative strategies for regulatory approval, anticipate and respond to changing regulatory requirements, and provide strategic leadership to influence the global regulatory environment to benefit the patients we serve. Regulatory Affairs is a key function within the business, and this role supports the ICT business. The Senior Regulatory Affairs Specialist will work primarily on software-based medical devices and will bring successful experience authoring software submissions through the FDA eSTAR programme and submissions to an EU Notified Body, together with a deep understanding of IEC 62304 and software lifecycle processes.

Key Skills & Requirements

• Prepare US and EU MDR submissions for new products and product changes to support timely approval for market release.
• Review significant regulatory issues with the Manager, as necessary, and resolve submission issues with Medtronic engineering partners, Geography Regulatory partners and regulatory agencies.
• Prepare regulatory strategies and plans, including worldwide compliance requirements.
• Provide ongoing support to project teams on regulatory issues and questions, and interpret and apply regulations and guidance appropriately.
• Provide business and product information to support development of regulatory strategies and requirements, and communicate that information to project teams.
• Provide regulatory support for currently marketed products, including review of labelling, changes to existing devices and associated documentation.
• Prepare submissions and reports for regulatory agencies as required.
• Apply a comprehensive understanding of technical and regulatory principles, theories and concepts, together with general knowledge of related disciplines.
• Engage and negotiate with international regulatory agencies, as needed.
• Review significant issues with the supervisor.
• Participate in project team meetings to plan regulatory strategies, including review of specifications, plans and reports; definition of target markets and distribution methods; and identification of Medtronic testing requirements.
• Provide regulatory analysis of the product portfolio and collaborate with other functions, including Marketing and Global Supply Chain.
• Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
• Work under general supervision and established procedures, independently determining and developing the appropriate approach.
• Maintain frequent inter-organisational contact and appropriate external contacts.
• Keep current on global directives, harmonised standards and procedures, and communicate changes that may affect cross-functional areas.
• Provide training and support to other members of the department.
• Perform other tasks, as required.

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.

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.

Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 63,920.00 EUR - 95,880.00 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).

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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.