Key Skills & Requirements 

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

• Minimum NFQ level 8 Bachelor's degree in a technical discipline with a minimum of 4 years of medical device regulatory experience or with an Advanced/Master’s degree with a minimum of 2 years of medical device regulatory experience.
• Experience working in a regulated medical device or biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies such as the FDA and PMDA, and working with cross-functional project teams.
• In-depth experience with FDA requirements and guidance documents, the EU Medical Device Regulation, IEC 62304, ISO 14971, ISO 13485 and other global regulatory requirements and quality standards.
• Working knowledge of Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).
• Positive track record of engaging with regulators.
• History of successful medical device submissions.
• Strong negotiation and written and oral communication skills.
• Strong organisational and time-management skills.
• Ability to manage multiple projects, work globally, prioritise activities, conduct team meetings and meet project deadlines.
• Ability to work independently under general direction.
• Proficiency in Microsoft Office, Microsoft Project, Adobe Acrobat and Agile.

Nice to Have

• Master of Science degree.

Medtronic offers a competitive salary and flexible Benefits Package

#INDJ #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. 

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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 AskHR@medtronic.com. 

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: 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.

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