Principal Regulatory Affairs Specialist

Stryker   •  

Redmond, WA

Industry: Pharmaceuticals & Biotech


8 - 10 years

Posted 165 days ago

This job is no longer available.

Job Description

Who we want:

  • Regulatory experts. Intelligent professionals who are sought out for their input on higher-level strategic decisions. 
  • Influential advisors. Inclusive mentors who provide direction and are motivated to help individuals take action and achieve success. 
  • Problem-solvers. Determined to find the right solutions that work for the group, internal/external customers and the business.  
  • Detail-oriented achievers. Focused professionals who are known for their strong analytical skills.
  • Game changers. Persistent associates who are passionate about Stryker’s mission to make healthcare better.

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