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

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, our mission is to develop innovative strategies for regulatory approvals, 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 Coronary and Renal Denervation business. As a Principal Regulatory Affairs Specialists, you use your expert knowledge to provide strategic direction and guidance to support this business.

Come for a job, stay for a career!

A Day in The Life Of:

• Engages with global regulatory agencies representing the company and ensuring the voice of the regulator is considered in developing global regulatory strategies.
• Engages with global international regulatory partners to support regulatory strategy for new products/therapies and changes to existing devices and combination products.
• Partners with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
• Directs and influences the preparation of documentation to support high quality regulatory submission dossiers.
• Leads regulatory filings to support submissions, license renewal and annual registrations. 
• Influence clinical evidence strategy to support labeling content, marketing claims and regulatory compliance. 
• Support manufacturing strategy via a robust change control approach to ensure global approval and implementation of product and process changes.
• Mentors and coaches’ other employees within the department and provides leadership support to ensure strong talent development.
• Keeps abreast of regulatory procedures and changes. Supports industry advocacy activity to shape the future of evolving regulatory requirements. Develops internal procedures to ensure continuous compliance with all regulatory requirements.
• Develops strategies for earliest possible global approvals of regulatory filings.
• Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
• Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.

Key Skills & Experience

• We are looking for a person qualified to Level 8 Science or Engineering Bachelor’s Degree/Masters. A Regulatory Affairs qualification is desirable, but not mandatory.  
• Regulatory experience in Medical Devices is desirable with QP qualification being an advantage and regulatory experience in API’s and pharmaceutical being strongly preferred. However, candidates with a minimum of 7 year’s relevant experience or an advanced degree with 5 years of experience will also be considered.
• You are a recognized expert, capable of managing large projects or processes. 
• 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, at times acting as a team leader.
• You are a strong coach/mentor and can provide coaching/training to other employees within the RA Department.
• You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behavior.
• You are a good communicator and fluent in English, both in writing and speaking with strong organizational 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. 

 

 

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: 86,720.00 EUR - 130,080.00 EUR | 

 

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

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
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.

Learn more about our business, mission, and our commitment to diversity here