Principal Regulatory Affairs Specialist

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A Day in the LifeThe Principal Regulatory Affairs Specialist is responsible for providing regulatory leadership and strategic support for product development, lifecycle management, and global market access activities for the Shiley product portfolio. This role partners cross-functionally with R&D, Quality, Manufacturing, Clinical, Marketing, Operations, and globalization regulatory teams to develop and execute regulatory strategies that support business objectives while ensuring compliance with applicable global regulations and standards.
The individual in this role operates with a high degree of independence, influences cross-functional decision-making, and may serve as the regulatory lead for complex projects, product portfolios, or business-critical initiatives.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 

This role entails developing and implementing regulatory strategies, managing regulatory submissions and internal documentations, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results through providing guidance and mentorship to team members, supporting their development and helping them navigate complex regulatory requirements.

Collaborate closely with cross-functional partners such as R&D, clinical, operations, and marketing to ensure regulatory needs are integrated into product development and lifecycle management. Occasionally represent the company in discussions with regulatory bodies and industry groups, supporting regulatory compliance and business objectives supporting Acute Care & Monitoring achieve regulatory success and maintain a competitive edge.

Come for a job, stay for a career!

A Day in The Life:

 The Principal Regulatory Affairs Specialist (Pr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Shiley™ product within the Acute Care and Monitoring operation unit. Activities include participation in new product development and change development projects, review and approve design control documentation, regulatory change assessments, author regulatory documents (MDR Technical Documents, STEDs, 510ks, letter-to-file) and supporting EU MDR implementation.

The Pr. RAS role translates regulatory requirements into project/product requirements and collaborates cross-functionally, while ensuring timely and high-quality execution of assigned regulatory deliverables. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices.

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

• Directs or performs coordination and preparation of document packages for regulatory submissions.

• Supports change control activities to support global approval and implementation of product and process changes.

• Leads or compiles all materials required in CE-Mark and FDA submissions, internal regulatory documentations, license renewal and annual registrations.

• Teams with other business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.

• Recommends changes for labelling, 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 have direct interaction with regulatory agencies on defined matters.

• Support regulatory compliance activities, including manufacturing site registration & QMS audits as needed.

• Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.

Key Skills & Experience  

• Level 8 Honor’s Degree Science or Engineering bachelor's degree/master's with a minimum of 7 years of relevant experience, preferably with US and EU Class II Medical Devices.

• Regulatory experience in Medical Devices industry 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. Ability to comprehend principles of engineering, physiology, and medical device use.

• You collaborate with global cross functional teams and create alignment with team members.

• Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements.

• Experience with disposable medical devices

• May provide guidance, coaching and training to other employees within job area.

• You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behavior.

• Ability to effectively manage multiple projects and priorities.

• Has an excellent attention to detail and are results oriented.

• Proven problem-solving skills with the ability to identify risks and escalate issues as appropriate.

• Good initiative and team player.

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. 

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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: 86,720.00 EUR - 130,080.00 EUR | 
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).