Great question! As discussed, the role of the regulatory department includes product development and post-market management which require some background of project management. Project management is crucial for those with regulatory roles. There are many different subcategories within the umbrellas of product development and post-market management that require specific knowledge, tools, and skills from a team of individuals that can essentially work together towards ensuring the medical device being developed is FDA approved and maintains its approval. Regulatory professionals must take on the skills associated with project management, including meeting deadlines, evolving with any unexpected constraints, managing teams and more, which makes project management crucial in the development and regulation of medical devices. 

Unfortunately, I do not have any experience with project management in regulatory affairs but hope to some day!

Thank you for good information.

However, I do not yet understand exactly the relationship between the regulatory professionals and project management.

Should the person who works project management, such as a project manager, be well aware of the regulatory rules?

Or is there a separate person who does regulatory work?

I have never worked in regulatory affairs, however, my understanding is that it is an essential segment of every industry, let alone the medical device industry. An individual working in regulatory affairs is responsible for overseeing product development, testing, manufacturing, and marketing to ensure said product is in compliance with state and federal regulatory statutes set in place by regulatory bodies such as the FDA and does exactly what it is intended/advertised/purposed to do. The objective is to protect public health by ensuring the safety and efficacy of products. To answer @wonbum-sohn's question, depending on the structural organization of the company, there are regulatory professionals who work with their sector or others within a company to ensure the products the company produces meet government regulations. For example, these regulatory professionals can be project managers themselves who lead a division that manages cross-functional teams and set timelines for getting the product to market or these individuals can be a member in a division that focuses on a specific aspect of the product (i.e. research and development, testing, manufacturing, marketing etc.). At first, I confused regulatory affairs with quality assurance, which I do have experience with, however quality assurance is more about products meeting internal and industry standards as well as safety standards for consumers.

Project management is essential for people with regulatory roles because they must manage a group, choose specific timelines, and manage the team's documents. I have never had any experience in a project management role working in regulatory affairs; however, I believe it is a tough job because you manage the team. With this on one's shoulders, I wonder what the average yearly salary is for a project manager in regulatory affairs. Also, to answer the question above about whether the manager should know the regulatory rules. I think this is very important because if one does not understand what they are managing, there is no possible way they can handle it correctly unless it is by chance. So, any manager must understand everything related to their job because the company will blame them if anything goes wrong. 

First, its important to consider the organizational structure when discussing what skills a certain role needs. In regulatory, there will be a department director that oversees multiple regulatory project leads (these are the RA point of contact for every project), and those leads may oversee junior regulatory roles that also provide project support. At the director and lead level, project management skills are essential in creating and adhering to strict regulatory submission timelines, however the Project Managers are typically a separate role from the regulatory affairs lead, who is just a team member on the project. Regarding the question of how much regulatory knowledge a project manager has to have, the PM should have a basic understanding of what every regulatory pathway is going to entail and how much work is associated with each timeline, but they do not need to be experts on the specifics and nuances of submissions, that is what the RA project lead is for and the PM's role is to work with the RA lead to create reasonable project plans and expectations based on the expertise provided. That's the beauty of having a project team - no one person has to be the expert in everything!

The regulatory role is crucial in the development of medical devices in order to meet all the requirements set by the FDA. As we can see from the lecture, the regulatory role breaks down in product development and post-market management. Regulatory people help the project team to verify their claims. They make sure the claims are legitimate and can be proven. They are also responsible for writing the 510(K) and gathering information for PMAs. They also write other documents required by the FDA such as RFD and IDE. The regulatory person remains in contact with the FDA throughout the project timeline. Additionally, regulators are responsible for product labeling. They ensure that labeling adheres to the original device claims presented in the PMA or 510(k). Furthermore, the regulator maintains readiness for inspection by FDA,vendors,auditors,etc.Regulating affairs project management is not something I have expertise in, but perhaps I will in the future!