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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 (PVH) therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Artery Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease, caring for over 1 million patients globally with lifesaving and life-enhancing therapies. Regulatory Affairs is a key function within the business and this role is supporting the PVH business.

Come for a job, stay for a career!

Location: Hybrid

A day in the life of:

• 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 submissions, license renewal and annual registrations.

• Teams with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support. Works with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.

• Recommends changes for labeling and internal documentation, reports for regulatory compliance.

• Keeps abreast of regulatory procedures and changes. Support review of 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 & GMP 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 5 years of relevant experience, preferably with Class III devices. A Regulatory Affairs qualification is desirable, but not mandatory.

• Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated 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.

• 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

#IJA

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.