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Associate Regulatory Affairs Specialist - ICT

Medtronic -
Parkmore, County Galway

Apply Now

Job details

Full-time
€41,360–€62,040 a year
4 days ago

Qualifications

Engineering
Bachelor's degree
Recruiting

Full 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 is supporting the Interventional Cardiology Therapies (ICT) operating unit.

Come for a job, stay for a career!

A Day in The Life Of:

Responsibilities may include the following and other duties may be assigned.

Supports or performs coordination and preparation of document packages for regulatory submissions.
Teams with other Regulatory Affair Specialists and International regulatory Specialists to provide regulatory support for changes to existing products.
Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Supports change control activities to support global approval and implementation of product and process changes.
Recommends changes for labeling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
May direct interaction with regulatory agencies on defined matters.
Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
Monitors and improves tracking / control systems.
Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives and hyperautomation.

Key Skills & Experience

We are looking for a person qualified to Level 8 Science or Engineering bachelor’s degree. A Regulatory Affairs qualification is desirable, but not mandatory.
0 – 1 years regulatory experience in Medical Devices and/or Pharmaceuticals or Software in medical devices is required.
You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
You collaborate with others and create alignment with team members.
You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behavior.
Ability to work independently and under general direction.

Medtronic offer a competitive salary and flexible Benefits Package

#LI-hybrid

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. ‌

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.

If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected] . ‌

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: 41,360.00 EUR - 62,040.00 EUR |

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

Apply Now

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