Who we want:
In this role, you will develop regulatory strategies and innovative solutions that support U.S. approval of our innovative medical products. You’ll work cross-functionally and collaborate with product development teams, evaluating new technologies. When products are ready to be released to the market, you’ll prepare U.S. regulatory submissions, including Premarket Approval (PMA) applications and 510(k) Premarket Notifications, and interact and respond to the FDA during the approval process. Additional responsibilities include reviewing device labeling and advertising materials, reviewing and signing off on manufacturing and design changes, and providing regulatory input. If you’re a detail-oriented specialist driven to make healthcare better, join our team and help millions of people lead more active, satisfying lives.
What you need:
• Bachelor’s degree in Engineering, Biological Sciences or equivalent combination of education and experience is acceptable.
• 8+ years of applicable Regulatory experience
• Preferred experience with Class II / III Medical Devices, software products, and electromechanical device experience.
Thorough understanding of the following is preferred:
FDA medical device regulations, guidance and labeling requirements
Medical device quality systems
Product development processes
What We Offer:
• A winning team driven to achieve our mission and deliver remarkable results
• Quality products that improve the lives of customers and patients
• Ability to discover your strengths, follow your passion and own your own career