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Regulatory Affairs Specialist

Software Technology Inc

Regulatory Affairs Specialist

Franklin Lakes, NJ
Full Time
Paid
  • Responsibilities

    Job Description

    Urgent need for a Regulatory Affairs Specialist for Franklin Lakes, NJ for a very long term contract.

    If you are interested and looking for opportunities please review the job details given below and share your latest resume with Amrutha.

    For more details please call or shoot an email.

    Title: Regulatory Affairs Specialist

    Duration: 1+ yr

    Location: Franklin Lakes, NJ

    Interview: Phone & In-Person

    Job description:

    This position is responsible for the preparation of regulatory submissions required to market new or modified medical devices in both the U.S. and Europe, and related regulatory affairs activities, such as development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business. Requires the analysis of data, problem solving analysis and in depth evaluations of various factors. May provide leadership by assigning work and resolving complex problems.

    RESPONSIBILITIES:

    • Coordinate, prepare, and follow up with FDA Premarket Notification [510(k)] submissions in a timely manner. Act as liaison with FDA regarding product clearance.
    • Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal “Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission.
    • Prepare technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
    • Submit notification to the Notified Body about significant changes to CE marked products in a timely manner.
    • Review/approve labeling, promotional and advertising materials to ensure regulatory compliance.
    • Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.
    • Represent RA in product life cycle development teams by reviewing, approving, and completing requirements.
    • Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary
    • Represent RA in design teams and projects by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.
    • Submit product listing to the FDA when deemed necessary.
    • Support International Registrations as it relates to product changes and/or new product launches
    • Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
    • Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers. Carry out the above tasks with minimal supervision.


    EDUCATION: B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry

    LICENSES OR CERTIFICATIONS: RAPS Certification preferred

    MUST--EXPERIENCE:

    • 3-5 years Regulatory Affairs experience in medical device regulations
    • Demonstrated success in taking products through FDA and EU Notified Bodies.
    • International product registration experience preferred.
    • Proficient in using Microsoft Word, Access, Excel
    • Strong communication and project management skills.

    MUST--KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES:

    1. Working knowledge of 510(k), MDD 93/42/EEC.

    2. Working knowledge of 21 CFR 820 -Quality System Regulation.

    3. Working knowledge of standards and FDA guidances.

    If you have any questions, please feel free to reach me via email or phone.


    Thank you,

    Amrutha Duddula
    Lead Talent Acquisition Specialist

    Software Technology Inc (STI)

    Phone : 732-664-8807

    www.stiorg.com

    www.linkedin.com/in/amruthad/