Regulatory Affairs Admin

Posted Date 20 Aug 2024



Experience Icon Experience 6 months Salary Salary 19USD - 29USD
Job Type Icon Job Type Full Time Company Company CONMED
Job Category Icon Job Category Computer Operators Qualification Icon Qualification BS Business
Gender IconGender Both Date Last Date 18 Nov
Vacancies IconVacancies 1 Remote IconRemote No
Location Location(s) Florida , United States

Description Job Description


The Regulatory Affairs Admin plays a crucial role in the Regulatory Affairs (RA) team, focusing on the accurate preparation and maintenance of regulatory documents. This remote position involves assisting with the preparation of Technical Files/Product Files, ensuring compliance with regulatory requirements, and providing administrative support to the RA department.

Key Duties and Responsibilities:

  • Document Preparation:

    • Prepare document packages for regulatory submissions for new and existing products, ensuring compliance with local and regional registration requirements and company policies.
    • Compile materials required for submissions, license renewals, and annual registrations.
    • Prepare copies of international documents, CE Certificates, CFG's, and other regulatory documents.
  • Technical File Maintenance:

    • Assist in updating and maintaining Technical Files for submission to the Notified Body, including changes in manufacturing and/or design.
  • Database and Administrative Support:

    • Maintain the Global RA database for the Corporation.
    • Provide administrative support to RA Department personnel.
    • Complete additional tasks as assigned by management.

Required Qualifications:

  • Education:

    • Associate degree in business or a related field.
  • Experience:

    • 6-12 months of experience in an administrative or clerical role.

Preferred Qualifications:

  • Experience:
    • Experience working with technical specifications and detailed paperwork.
  • Skills:
    • Strong computer skills.
    • Strong organizational, written, and verbal communication skills.
    • Ability to handle multiple priorities simultaneously.

Compensation:

  • Pay Rate: $19.00 to $29.00 per hour.
    • The actual compensation may vary based on geographic location, work experience, education, and skill level.

Travel:

  • Travel Requirements: 0-20% travel.

Sponsorship:

  • Eligibility: This position is not eligible for employer-based sponsorship.

Benefits:

  • Competitive Compensation:
    • Excellent healthcare coverage including medical, dental, vision, and prescription.
    • Short & long-term disability plus life insurance (cost paid fully by CONMED).
    • Retirement Savings Plan (401K) with dollar-for-dollar match up to 7% per pay period.
    • Employee Stock Purchase Plan at a discounted price.
    • Tuition assistance for undergraduate and graduate courses.


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