Regulatory Affairs Admin

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.