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

    Merit Medical Systems Inc.
    Merit Medical Systems Inc. Tijuana

    hace 2 días

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    Educación / Formación
    Descripción

    Why Merit?

    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 are making a difference in the lives of patients around the world.

    Essential Functions Performed

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

    Essential Physical/Environmental Demands

    • Lifting - Not to exceed 50 lbs – local practice may apply.
    • Writing
    • Sitting
    • Standing
    • Bending
    • Visual acuity
    • Color perception
    • Depth perception
    • Reading
    • Field of vision/peripheral

    Summary of Minimum Qualifications

    • Education and/or experience equivalent to a Bachelor's Degree in a technical field, such as biological, physical, engineering, or material science disciplines, and 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, etc.
    • 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

    Comments

    Infectious Control Risk Category III: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.

    As a member of Merit, you are eligible for:

    • Life insurance, major medical expenses, and funeral expenses.
    • Comprehensive medical coverage for family members.
    • Extended holidays, vacation days, and a higher-than-average vacation bonus.
    • Two personal days off per year (one birthday and one floating holiday).
    • Two additional festive days (Good Friday and Christmas).
    • A savings fund with no cap.
    • Annual bonus based on performance.
    • Free meals.
    • Merit Academy – Continuous training.
    • Social Responsibility Committee.


  • Merit Medical Baja California

    ESSENTIAL FUNCTIONS PERFORMEDDetermines global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.Participates on various teams to define regulatory requirements of U.S. and international submissions, ...

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