Senior Regulatory Affairs Specialist - Mervue
Medtronic invites applications for the
Senior Regulatory Affairs Specialist - Mervue
role.
The position is based in Galway, County Galway, Ireland.
As part of Medtronic's Acute Care & Monitoring unit, the Senior Regulatory Affairs Specialist (Sr. RAS) drives regulatory strategy, manages submissions, and ensures compliance for the MicrostreamTM Capnography Monitoring product portfolio.
Key Responsibilities
Direct coordination and preparation of regulatory submission document packages.
Support change control activities for global product and process approvals.
Lead or compile materials required for CE-Mark and FDA submissions, license renewal, and annual registrations.
Collaborate with Regulatory Affairs Specialists and international regulatory staff on new product introductions and changes to existing products.
Recommend labeling, manufacturing, marketing, and clinical protocol/report changes to meet regulatory standards.
Maintain awareness of evolving regulatory procedures and internal compliance procedures.
Interact with regulatory agencies on defined matters and provide regulatory support for site registration and GMP audits.
Identify and develop best practices within the Regulatory Affairs Department.
Qualifications & Experience
Bachelor's or Master's degree in Science or Engineering; Class III Medical Device experience preferred.
Minimum 5 years of regulatory experience in Medical Devices, Pharmaceuticals, or related regulated industry.
Strong technical knowledge of engineering, physiology, and medical device use.
Experience with FDA, EU MDR, Regulation (EU) ********, and other international regulatory requirements.
Demonstrated ability to manage multiple projects and priorities with attention to detail.
Excellent problem-solving, initiative, and teamwork skills.
Ability to provide guidance, coaching, and training to other employees.
Benefits & Compensation
Competitive salary, short-term Medtronic Incentive Plan (MIP), and comprehensive benefits package designed to support career growth.
Medtronic is an Equal Opportunity Employer.
All qualified applicants are encouraged to apply.
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