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Principal Regulatory Affairs Specialist in Redmond, WA at Stryker Corporation

Date Posted: 11/25/2018

Job Snapshot

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

About Stryker
Together with our customers, we are driven to make healthcare better. Stryker, previously Physio-Control, is the leader in life-saving and emergency medicine technology and data solutions, serving EMS, hospital, military, and emerging models of healthcare.  We make the legendary LIFEPAK® brand of patient monitors and defibrillators – considered one of the most powerful tools in emergency medicine.  Join our Team and see how you can flourish in an environment rich with advanced technology, innovative medical science, and high-performance culture. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO   

      Work From Home: No

      Travel Percentage: None

      Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

      Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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