Regulatory Affairs Specialist - 12 Month Contract

Job Description

Travel

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, based in Galway our mission is to develop innovative strategies for regulatory approval, 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 (CRDN) business for a 12 month contract.

Come for a job, stay for a career!

A Day in The Life Of:

• Directs or performs coordination and preparation of document packages for regulatory submissions.
• Teams with other Regulatory Affair Specialists and International regulatory Specialists to provide regulatory support for changes to existing products.
• Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Supports change control activities to support global approval and implementation of product and process changes.
• Recommends changes for labeling, 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 direct interaction with regulatory agencies on defined matters.
• Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
• Monitors and improves tracking / control systems.
• 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 A Regulatory Affairs qualification is desirable, but not mandatory.
• Regulatory experience in Medical Devices and/or Pharmaceuticals and/pr software in/as a medical device is required, and related relevant experience will also be considered.
• 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.
• You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behavior.
• Ability to work independently and under general direction only.
• 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

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