Senior Regulatory - New York - Medella Life

    Medella Life
    Medella Life New York

    4 days ago

    Description

    Role Overview


    This Hybrid position combines senior responsibility for Regulatory Affairs and Quality Management. You will work closely with engineering, product, and leadership teams, taking ownership of compliance activities while supporting innovation in a growing team.

    Key Responsibilities


    Regulatory Affairs

    • Lead and support US regulatory strategy for medical devices
    • Prepare, review, and maintain FDA submissions
    • Act as primary contact for FDA communications and inspections
    • Monitor and interpret relevant FDA guidance applicable to software-enabled medical devices
    • Support regulatory assessment of product and software changes

    Quality Management

    • Own and maintain the Quality Management System in compliance with FDA QSR
    • Ensure effective implementation of design controls and lifecycle documentation
    • Support compliant software development and change management processes
    • Lead CAPA, non-conformances, deviations, and change control

    Cross-Functional Collaboration

    • Work closely with Engineering, Product, Clinical, and Operations teams
    • Support supplier and partner oversight, including software and service providers

    Candidate Profile

    • Degree in Engineering, Life Sciences, Computer Science, or a related discipline
    • 7+ years of experience in Regulatory Affairs and/or Quality Management within medical devices
    • Strong working knowledge of FDA regulations
    • Experience with software-enabled medical devices; SaMD experience is an advantage
    • Solid understanding of ISO 14971 and design control requirements (21 CFR 820)
    • Strong communication and stakeholder management skills

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