Senior Regulatory Affairs Specialist - SH
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 Structural Heart 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 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 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 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
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