Principal Regulatory Affairs Specialist

Medtronic · County Westmeath, Ireland

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RegulatoryFull-timeCompany career page

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What they're looking for

Bachelor's degree in science or engineering; master's preferred
Minimum 7 years medical device regulatory experience
FDA and EU MDR regulatory requirements knowledge
Experience with Class II medical devices, US and EU markets
Strong technical knowledge of engineering and medical device principles
Expertise reviewing advertising and promotional materials for devices

What you'll be doing

Develop and execute regulatory strategies for Shiley product portfolio and lifecycle management
Direct preparation of regulatory submission packages including 510(k)s, MDR documents, and CE-Mark materials
Support change control and global approval activities for product and process modifications
Collaborate with R&D, quality, manufacturing, clinical, and marketing teams on regulatory requirements
Provide guidance and mentorship to regulatory team members on complex requirements

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Date posted4 days ago

Last source check1 day ago

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