In lecture, the quality unit was mentioned. It can vary from one company to another. It can range from regulatory affairs, quality assurance, quality control, to document control, training, and complaints. I am highly interested in Regulatory Affairs. Has anyone had any experience in that field in the industry? If yes, can you share your experience. Also, are there any courses that are offered in NJIT that would help you excel in that position?
Regulatory Affairs is an interesting field, and while I haven’t worked in it myself, I know that it plays a vital role in bridging the gap between companies and regulatory bodies, ensuring compliance with regulations and smooth product approvals.
I'm not entirely sure if there are many courses at NJIT covering this, but perhaps you could look into something online. You might want to look into courses in regulatory science, FDA regulations, and quality systems. Also, some courses related to bme, clinical trials, and maybe intellectual property law could also give you a solid foundation for understanding the complexities of product approvals and compliance
Maybe you could look into internships or co-op programs where you can gain hands-on experience in Regulatory Affairs.
Regulatory Affairs is a great field to explore. From my own industry experience and from speaking with hiring managers, there is always a high need for employees knowledgeable about the regulatory process. I've personally been involved in a few Corrective and Preventative Actions (CAPAs), so I understand the need for regulatory affairs and their knowledge of CAPA systems, communication with regulatory agencies, and ensuring proper documentation and reporting. I have not taken a course at NJIT directly related to regulatory affairs, and I know this post was shared 3 years ago, but for anyone reading this, I would suggest taking ENGR350. It is an intellectual property course that outlines patent and trademark regulations and communication with the FDA. The IP and Regulatory groups in biomedical engineering companies are closely related and they oftentimes collaborate. Both groups' considerations affect the development and commercialization of products and complement one another.