Senior Specialist, Regulatory Affairs

Job Title: Senior Specialist, Regulatory Affairs

Role Level: Individual Contributor

Supervisor/Manager Title: Senior Manager, Regulatory Affairs

Job Location & Environment: Irvine, CA – Corporate Office Environment

Job Description Summary: Responsible for global regulatory affairs communication, regulatory negotiation and correspondence tracking, serious adverse event reporting, post-market surveillance, competitive intelligence, and maintenance of standards program. Under supervision, prepares clinical, pre-market and post-market submissions and query response development and communicates with regulatory authorities and partners. Provides expertise in translating regulatory requirements into practical, workable plans. Provides counsel to project teams as applicable. Ensures timely preparation of organized and scientifically valid submissions. Interacts with internal departments and external representatives (i.e., distributors, legal agents, regulatory agencies).

Job Responsibilities:

• Under supervision, lead the preparation, submission, and maintenance of high-quality global filings for investigational device authorizations and registrations, annual reports, and amendments/supplements, communicating with regulatory authorities as applicable.
• Serve as the regulatory team member of product development and sustaining teams, providing clear direction and input to assure that applicable global requirements are incorporated in the development process and to drive attainment of company objectives.
• Interpret existing or new regulatory requirements as they relate to company products and procedures, labeling, marketing projects, clinical studies, testing, or record keeping.
• Manage and oversee submission of serious adverse event reporting, Medical Device Reports (MDRs), Vigilance reports, field safety notices, and other communication with competent authorities and other external stakeholders.
• Review and approve FMEAs/risk analyses, protocols, reports, other technical documents.
• Review product labeling for compliance with global labeling regulations.
• Maintain regulatory intelligence through continuous monitoring of regulatory landscape.
• Review and approve document change orders and prepare letters-to-file.
• Update departmental procedures as required.
• Produce monthly reports on global activities, issues, recommendations, and plans going forward.
• Participate in external audits as needed.
• Perform other duties as assigned by supervisor.