Senior Regulatory Affairs Specialist - Onsite

Medtronic•Irvine, CA

6d•$92,000 - $138,000•Onsite

About The Position

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.

Requirements

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.
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.
U.S. work authorization is required for roles below Principal level.

Nice To Haves

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.

Responsibilities

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.