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  • Senior Regulatory Affairs Specialist - Tijuana - Merit Medical Systems Inc.

    Merit Medical Systems Inc.
    Merit Medical Systems Inc. Tijuana

    hace 3 semanas

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    Descripción

    About Us

    Merit Medical's mission is to develop innovative medical devices that improve lives. Our goal is to integrate and develop people who want to build through hard work, teamwork, and commitment, devices that save lives. Together, we're making a difference in the lives of patients worldwide.

    Job Summary

    The Regulatory Coordinator will be responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level for Europe, the United States, and other countries. This role ensures regulatory compliance for assigned product lines, coordinates recalls, identifies relevant standards and guidance documents affecting Merit's business and products, assists with FDA facility inspections, Notified Body audits, and other internal audits.

    Key Responsibilities:

    • Determines global regulatory pathways for various projects, including product classification and type of regulatory submission or rationale required.
    • Participates in teams to define regulatory requirements of U.S. and international submissions, Technical Files, or regulatory rationales.
    • Identifies guidance documents, international standards, Consensus Standards, and assists teams with their interpretation.
    • Prepares regulatory submissions to the FDA, the Notified Body, and other regulatory authorities.
    • Prepares IDEs and PMAs and assists with clinical trials when required.
    • Interacts with various levels of management, external agencies, and companies.
    • Analyzes and makes recommendations regarding field complaints.
    • Develops, maintains, and analyzes department systems and provides training when needed.
    • Remains current on developing regulations and revises systems as necessary.
    • Participates in and assists with FDA facility inspections, Notified Body Audits, and other inspections and audits as directed.
    • Assists with supervision of department staff, as directed.
    • Performs other related duties and tasks as required.

    Requirements:

    • Bachelor's Degree in a technical field such as biology, physics, engineering, or material science, plus six years of related industry experience.
    • Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485.
    • Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers.
    • Self-motivated, self-directing, strong attention to detail, and excellent time management skills.
    • Strong interpersonal skills and the ability to communicate well verbally and in writing with others.
    • Demonstrated computer skills, preferably spreadsheets, word processing, database, internet research, and other applicable software programs.

    Competencies:

    • Regulatory submission/rationale preparation
    • Global Regulatory paths/strategies
    • Computer skills/internet research
    • Interpersonal/communication skills
    • Regulatory system development/training
    • Field Action coordination and reporting
    • Product development and change qualification processes

    Benefits:

    • Lifelong learning opportunities
    • Comprehensive medical coverage
    • Cash savings plan without limits
    • Annual bonus for performance
    • Free meals
    • Award-winning employee recognition program

    Estimated Salary: $80,000 - $110,000 per year


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