Regulatory Specialist

Regulatory Specialist Job Description Template

Our company is looking for a Regulatory Specialist to join our team.

Responsibilities:

  • Prepares and submits US FDA pre-sub, 510(k) and other product submissions and prepares internal regulatory evaluations according to FDA guidelines.

Requirements:

  • Excellent communicator and writer;
  • Preparation of draft responses to questions regarding procedural issues for agency filings;
  • Expert with Microsoft products;
  • Preparation of agency filings with state and federal authorities;
  • Monitor status of proposed legislation and regulations;
  • Liaise with outside counsel on all regulatory affairs as needed;
  • Preparation of licensure applications;
  • Understanding of Medicare and Medicaid;
  • Bachelor’s degree;
  • Multi-state experience preferred;
  • Legal experience preferred;
  • Healthcare regulatory experience preferred;
  • Preparation of certificate of need;
  • Ad hoc projects requiring attention to detail.