Regulatory Affairs Specialist

  • $80,000.00 - $85,000.00/year
  • LeConte Recruiting Firm has partnered with a manufacturing company in the Knoxville area to locate a Regulatory Affairs Specialist for their manufacturing facility.

     As a Senior Regulatory Affairs Specialist with this fast-growing, Class II medical device company, you will be responsible for product submissions, license renewals, periodic updates and registrations to regulatory agencies. You will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues.


     Core Job Responsibilities: 
    • Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process. 
    • Complete submissions to FDA, EU regulatory entities.
    • Create and maintain product EU technical files.
    • Supervise Regulatory Affairs consultants as required.
    • Other duties as assigned 


    Requirements for the Regulatory Affairs Specialist
    • Bachelor's degree om Science or equivalent
    • At least 3-5 years of relevant experience within the regulatory affairs discipline or in a regulated industry (e.g, medical devices, pharmaceuticals)
    • Knowledge of ISO 13485/9001
    • Knowledge of 21 CFR 820-Quality System Regulation
    • Knowledge of 21 CFR 210 & 211 cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceuticals

    Salary for the Regulatory Affairs Specialist is $80,000-$85,000

    Benefits Package
     
    • Paid time off
    • Health insurance
    • Dental insurance
    • Healthcare spending or reimbursement accounts such as HSAs or FSAs
    • Retirement benefits or accounts
    • Education assistance or tuition reimbursement

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