Regulatory Specialist Job Description Template
Our company is looking for a Regulatory Specialist to join our team.
- Prepares and submits US FDA pre-sub, 510(k) and other product submissions and prepares internal regulatory evaluations according to FDA guidelines.
- 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.