Job Summary: Under the direction of the Director of Regulatory Affairs, the Clinical Regulatory Affairs Associate supports the Regulatory Affairs Department, and all its functions, including: Regulatory Submissions and meetings with regulatory bodies, regulatory clinical discussions, maintaining Bunnell's regulatory status, and assisting other departments in the regulatory process.
Responsibilities/Duties may include the following:
1. Maintain good regulatory status in the United States. This includes FDA annual registration, annual report for PMA devices, regulatory upkeep for 510k products, etc.
2. Maintaining good regulatory status in Canada including annual license renewal and documenting changes that do not meet the level of a significant change and submission of those changes that do meet the level of significant change.
3. Maintaining good regulatory status in Australia by working with the sponsor and documenting changes that do not require notification by not being a substantial change and providing documentation to the sponsor for those changes that do meet the level of substantial change.
4. Assist and instruct R&D and Production with Design Control documentation, especially the clinical aspects.
5. Develop or modify requirements documents for new and existing products using input from clinicians, marketing, engineering, and risk management.
6. Have a thorough knowledge of design and safety standards, both international and domestic, and applies this knowledge to the creation of requirements and verification and validation documents.
7. Work with Research and Development (R&D) and Manufacturing to develop test protocols and the final test reports that may be submitted to the regulatory agencies.
8. Help with review of internal documentation for Regulatory Affairs.
9. Support and assist with company regulatory submissions and meetings.
10. Support company decisions with regulatory burden of introduction of devices into new countries.
11. Complete special projects as needed
Minimum Qualifications:
- Bachelor of Science or greater in Respiratory Therapy or equivalent.
- Ability to verbally communicate clinical implications of devices.
- Proficient writing skills, especially to communicate changes in device and clinical implications of these changes to regulatory agencies.
Preferred Experiences:
- Knowledge of Basic Statistics
- Research with ventilation: ability to write and follow protocols and write final reports.
- Ability to apply clinical knowledge to input documentation for product development.
- Ability to apply standards to development and/or testing.
