I was joined by Mr. David Pudwill, a Regulatory Affairs expert for both medical devices as well as combination products.

David holds a Bachelor's Degree in Biomedical Engineering and his Masters in Mechanical Engineering. David actually spent 9 years of his career working directly for the FDA as a lead medical device reviewer. After that he spent several years with a med-tech organization called Convatec where he was responsible for developing and growing Global Regulatory and Quality teams as large as a hundred people worldwide, while developing new ways of thinking about Regulatory Affairs for both in market support as well as new product development and a digital transformation.

David currently runs a consulting/educational based firm called Mr. Regulatory. The organization really started as an educational platform primarily discussing all things regulatory, guidance documents, things like that on his Youtube channel. He is in the process of growing the content on that channel, but he is also providing consulting services to a variety of start up organizations across the med-tech space when it comes to Regulatory strategy and he is really helping organizations primarily who don’t yet have a regulatory in house force be able to define the right path and gain access to the market.

During our conversation, David and I discussed his experiences with the FDA as well as how he decided to start his own show vs working for another organization.

Some key highlights we discussed:

-What did working for the FDA teach him that was beneficial for working in-industry

-What mistakes did he make as a leader that he learned from and is better off because of

-What do companies get wrong about Regulatory Affairs? (timing, importance of the function, submission documentation, etc)

-What mistakes does he see up and comers, who are striving to be promoted, making along their journey?

...and so much more