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The healthcare industry evolved greatly over the last 10 years. As a result, the tasks of Regulatory Affairs Professionals have changed accordingly. New technologies such as artificial intelligence and machine learning (e.g., decision support systems), home virus detection kits, wearable patient monitoring devices, companion diagnostics and precision medicine are already being used today. In the wake of such innovations and the resulting revision or creation of new regulations, Regulatory Affairs Professionals must continually expand their knowledge.
To obtain and maintain regulatory approval of healthcare products, Regulatory Affairs Professionals must fulfill the following core tasks:
- Regulatory strategies
- Implementing regulatory measures
- Adhering to quality management
- Solving trade-related issues
- Negotiating/communicating with authorities
- Crisis management