Regulatory Affairs Specialist - PVH

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

Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. This position will reside in the Peripheral Vascular Health organization that cares for millions of patients globally with life-enhancing therapies.

The Regulatory Affairs Specialist is responsible for worldwide regulatory activities to introduce new products (Class II and Class III) to global market, maintain existing products and provide advice on regulatory requirements. The Regulatory Affairs Specialist is responsible for assessing device changes for regulatory implications and for performing relevant regulatory actions in support of the implementation of these changes.  This role focuses on a wide variety of regulatory tasks to allow the Regulatory Affairs Specialist to make the most of his/her existing knowledge base while growing his RA skill set daily working within a collaborative team environment. The Regulatory Affairs Specialist reports to the Regulatory Affairs Manager.

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.

• Team with Operating Unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for market expansion of new products/therapies.

• Lead or compile all materials required in submissions, license renewal and annual registrations. Work with engineers and technical experts to address questions from regulatory agencies.

• Provide support to currently marketed products as necessary. This includes reviewing labeling, product or process changes as well as supportive documentation for changes requiring RA agency review. Prepare submissions and reports for FDA or provide support and documentation for international submissions.

• Maintain proficiency in worldwide regulatory requirements. 

• Establish and maintain good relationships within the RA department, cross functional teams and assist in developing and maintaining positive relationships with device reviewers through verbal and written communications.

• May assist in negotiations with the FDA or other regulatory agencies for defined projects.

• Other tasks, as assigned.

Key Skills & Experience

• Minimum NFQ Level 8 Bachelor’s degree in Regulatory Science, Pharmaceutical, Biomedical or related medical/scientific field with minimum 2 years of relevant experience in medical device industry.

• Or Master’s degree in Regulatory Science, Pharmaceutical, Biomedical or related medical/scientific field with no prior experience.

Nice to have:

• Experience working with Class II/III medical devices.

• Experience with FDA requirements, guidance documents, Medical Device Directive (MDD), Medical Device Regulation (MDR), medicinal consultations and/or other global regulatory requirements and quality standards.

• Effective negotiation and written/oral communication skills.

• Effective interpersonal, organizational and time management skills.

• Effective team member.

• Detail-oriented

Medtronic offer a competitive salary and flexible Benefits Package

#INDJ

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: 46,400.00 EUR - 69,600.00 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