Bruce McKean-Dir Reg Affairs-Rimsys-A Rewarding Career in Reg Affairs & Software
The Med-Tech Talent Lab · Mitch Robbins
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Show Notes
Bruce McKean a 25+ year veteran of Regulatory Affairs & Quality within the Med-Tech space. Bruce spent much of his career focusing on Quality Management & Regulatory Compliance with Federal and International Regulations for Electromechanical, Implantable, and Software as a Medical Device products. He spent the vast majority of his career with Philips, starting as a Quality Engineer but rising up the ranks quickly and ultimately becoming one of the Directors of Quality & Regulatory.
Today, Bruce serves as the Director of Regulatory for Rimsys. Rimsys provides world-leading Regulatory Information Software for medical technology companies that digitizes, automates, and creates regulatory order. The company makes it easy to navigate the pillars of Regulatory Affairs including product registrations, standards management, essential principles, and regulatory intelligence.
Some highlights of what we covered:
-How Bruce ended up moving from Quality to Regulatory and how you can get into Reg Affairs yourself
-Learnings from M&A work (systems, culture, etc.) as it relates to RA/QA
-Exciting things happening at Rimsys that are making it easier for the RA/QA community at large within the Med-Tech space
...and so much more!
Bruce McKean on LinkedIn: https://www.linkedin.com/in/bruce-mckean-15106535/
Rimsys on the web: https://www.rimsys.io/