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.
Overview
Medtronic, Regulatory Affairs, 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.
This role supports the Structural Heart business.
A Day in the Life: Directs or coordinates the 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 materials required in submissions, license renewals and annual registrations; collaborates with Regulatory Affair Specialists and international staff to provide regulatory support for new products/therapies and changes to existing products; works 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; develops internal procedures to ensure continuous compliance; may interact with regulatory agencies on defined matters; supports regulatory compliance activities including manufacturing site registration and GMP audits; identifies and develops best practices within the Regulatory Affairs Department and continuous development initiatives.
Responsibilities
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 in Science or Engineering; bachelor's or master's with a minimum of 5 years of relevant experience, preferably with Class III Medical Devices.
A Regulatory Affairs qualification is desirable but not mandatory.
Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required.
Dynamic team player capable of working effectively and proactively on activities both individually and in teams.
Strong technical knowledge; ability to think critically and make sound decisions; understanding of engineering, physiology, and medical device use.
Collaborates with global cross-functional teams and creates alignment with team members.
Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) ********, and international regulatory agency requirements.
May provide guidance, coaching and training to other employees within the job area.
Sets high standards and drives accountability; models ethical behavior.
Ability to manage multiple projects and priorities; excellent attention to detail and results orientation.
Proficient in data analysis techniques, including statistical modeling, trend analysis, and data visualization.
Physical & Other Requirements
Medtronic offers a competitive salary and flexible benefits package.
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 and offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for 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, we experiment, create, build, improve and solve.
Learn more about our business, mission, and commitment to diversity here.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
Industries
Medical Equipment Manufacturing, Hospitals and Health Care, and Pharmaceutical Manufacturing
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