Senior Regulatory Affairs Specialist - Onsite

We anticipate the application window for this opening will close on - 5 Sep 2026   Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life                     The Neurovascular Operating Unit develops technologies used in the treatment of acute ischemic stroke and other neurovascular conditions. The team partners across regulatory, quality, engineering, clinical, and commercial functions to maintain compliance throughout the product lifecycle and support regulatory pathways that enable continued access to innovative therapies in global markets. This position is based onsite in Irvine, California. Team members are expected to work on-site at least 4 days per week to support cross-functional collaboration and the execution of regulatory activities. Travel is expected to be minimal. The Senior Regulatory Affairs Specialist supports regulatory compliance and product lifecycle management activities for a portfolio of neurovascular medical devices. This role is responsible for evaluating product changes, preparing regulatory submissions, maintaining regulatory documentation, and providing regulatory guidance to cross-functional teams to support business objectives and market access requirements.

Provide regulatory strategy and guidance for product modifications and lifecycle management activities. Prepare and submit Pre-Submission, Investigational Device Exemption (IDE), IDE Supplement, Premarket Approval (PMA), PMA Supplement, and 510(k) regulatory submissions. Support technical documentation development and maintenance for European Union Medical Device Regulation (EU MDR) compliance and CE Mark activities. Assess product, labeling, manufacturing, and process changes to determine regulatory impact and document regulatory decisions. Partner with engineering, quality, clinical, marketing, and other cross-functional teams to ensure regulatory requirements are incorporated throughout the product lifecycle. Serve as the primary regulatory representative with regulatory authorities and Notified Bodies, including support for agency interactions and responses. Review promotional and advertising materials for compliance with applicable regulatory requirements. Maintain regulatory records, procedures, and submissions while supporting internal and external audits as required.

Bachelor's degree in Science or Engineering and 4+ years of medical device regulatory affairs experience; or an advanced degree and 2+ years of medical device regulatory affairs experience. Experience supporting U.S. Food and Drug Administration (FDA) medical device submissions and regulatory compliance activities. Experience managing multiple regulatory projects in a regulated medical device environment.

Regulatory Affairs Certification (RAC). Experience with 510(k), Investigational Device Exemption (IDE), Premarket Approval (PMA), or international medical device submissions. Knowledge of European Union Medical Device Regulation (EU MDR), ISO 13485, and ISO 14971 requirements. Experience supporting global regulatory compliance and market access activities. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and