Sample interview questions: How do you ensure compliance with regulations related to the use of mobile health (mHealth) applications for remote patient monitoring in medical research?
Sample answer:
- Stay updated on relevant regulations. Regulatory requirements for mHealth applications are constantly evolving, so it’s important to stay up-to-date on the latest changes. This includes reading regulatory guidance documents, attending industry conferences, and networking with other professionals in the field.
- Develop a comprehensive regulatory strategy. Once you understand the relevant regulations, you need to develop a comprehensive regulatory strategy for your mHealth application. This strategy should include a plan for obtaining the necessary regulatory approvals, as well as a plan for maintaining compliance with the regulations once the application is approved.
- Work with a qualified regulatory consultant. If you don’t have the internal resources to develop and implement a regulatory strategy, you should consider working with a qualified regulatory consultant. A good consultant can help you navigate the regulatory landscape and ensure that your mHealth application complies with all applicable requirements.
- Submit a comprehensive regulatory dossier. When you submit a regulatory application for your mHealth application, you need to include a comprehensive dossier of supporting documentation. This dossier should include information about the application’s safety and effectiveness, as well as information about the company that developed the application.
- Respond to regulatory inquiries promptly. If the regulatory authorities have any questions about your mHealth application, you need to respond promptly and thoroughly. Failing to respond to regulatory inquiries in a timely manner can delay the… Read full answer
Source: https://hireabo.com/job/2_3_19/Regulatory%20Affairs%20Specialist