Medtronic

Healthcare

RegulatoryAffairsSpecialist

€48–73k Galway, County Galway, Ireland FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Regulatory Affairs Specialist at Medtronic. Skills: Regulatory affairs, Medical devices, Global regulatory requirements. Lead submissions compilation. Compile license renewal materials”

Industry & Context.

Healthcare

What They're Looking For.

Must Have

NFQ Level 8 Bachelor’s degree, 2 years relevant experience, Master’s degree no experience

Nice to Have

Experience with Class II/III devices, Experience with FDA requirements, Experience with MDD, Experience with MDR, Experience with medicinal consultations, Experience with global regulatory requirements, Experience with quality standards

What You'll Do.

Lead submissions compilation

Compile license renewal materials

Compile annual registrations materials

Address agency questions

Provide support to marketed products

Review labeling changes

Review product changes

Review process changes

Prepare FDA submissions

Provide international submission support

Maintain worldwide regulatory requirements proficiency

Establish RA department relationships

Establish cross-functional team relationships

Develop positive reviewer relationships

Assist in FDA negotiations

Assist in agency negotiations

How You'll Work.

Team & Collaboration

Cross-functional teams; RA department; Device reviewers

Communication Scope

Written communication; Verbal communication

Full Job Description

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 for new and existing Class II and Class III devices 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. **_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. * 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 documentati

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