Company summary: An established, global medical device biotech is looking to add a Principal Specialist of Regulatory Affairs onboard their already established team. These guys are working with complex, class III products, and are looking for an individual with a strong medical device background to come play a supporting role in their product development.
With a variety of comprehensive products already out on the market, these guys have a proven track record of success and are showing no signs of stopping, especially as the market continues to grow. If you are interested in learning more - please don't hesitate to apply!
Responsibilities:
-Provide support for regulatory PMA and class III device products
-Prepare relevant regulatory submissions for class III products
-Collaborate with cross functional teams and global teams
-Review QA and R&D output for compliance
-Other duties as assigned
Requirements:
-BS or higher in a scientific discipline
-8+ years of regulatory experience, preferably in devices
-Project management experience
-Knowledge of FDA/EU MDR regulations and requirements
-Strong work ethic
