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Roles of the Regulatory Department

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(@jh597)
Posts: 77
Trusted Member
 

Product development and post-market management differ in that product development includes the process of designing and manufacturing the product, whereas post-market management deals with the management of the product after it is released. Product development requires considering different FDA regulations as well as ensuring requirements are met in order to be FDA-approved, while post-market management addresses issues that result after the product has already been produced. These issues can result from customer complaints and audits from different organizations such as ISO and the FDA. Both sectors are very important since regulations can change over time, meaning that the device can always be improved. In terms of which interests me more, it would be product development due to the ability to be involved while the product is still being planned. Product development would be more interesting to me due to the ability to be involved in the design process as well as ensuring that different design considerations meet FDA regulations. I think both are equally important due to the fact that regulations evolve over time. Therefore, it is important that the devices are made to follow FDA regulations as well as be improved to address new regulations that may arise. 

 
Posted : 28/01/2023 12:40 am
(@sm2744)
Posts: 77
Trusted Member
 

I think that both product development and post-market management are equally important. Personally, I think I would enjoy a role in post-market management more than product development. I like making sure that products behave the way they are intended to so I think I would love collecting customer feedback and making sure that our product is safe and changing lives for the better. If there was a report of a malfunctioning batch of devices created by one of our facilities, it would need to be flagged and corrected immediately. I think this side of regulatory is more client facing and would bring me satisfaction with my job. 

In cases of recalls, I believe that the product development side of regulatory is involved with post-market management. This is because if post-market finds adverse affects and recalls, or if the FDA makes them recall, product development needs to quickly be able to come up with a design that fixes the issues that the device is being recalled for. They would have to come up with solutions that address that recall and also potential consequences that their redesign may have to create a safer product. 

 
Posted : 28/01/2023 5:20 pm
(@hk425)
Posts: 39
Eminent Member
 

I would like to work in product development. Product development is the core work of any company that wants to create something and sell it. The product that a company puts out essentially decides the company’s worth and place in the market — it’s to cultivate, grow, and maintain a company’s profit in the market by satisfying its consumers. And the root of this supplier-consumer relationship starts with product development. It’s important to know what the consumers want and how the company can develop that, ensuring good quality. Product development also has more scope for creativity than management. It includes factors like the conceptualization, design, development, testing, implementation, and re-working of the product if something goes wrong after its release. I think that this type of work allows a more creative, hands on approach to a job, and also offers the most growth, especially if you are just starting out in the industry. It also makes transition into management jobs easier, because you get to learn what type of work you’re managing. While the post-market management is important in regulating the product development, release, marketing, etc., I think product development is more important because a good product makes post-market management easier. A faulty or low quality product makes post market surveillance harder, because it means that the company has to assess what went wrong, fix it, and market it all over again. Not only is this process expensive for the company and more work for the employees, once a product like that is released into the market, the consumer’s might not trust that company again to produce a proper product.

 
Posted : 29/01/2023 4:03 pm
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