Requisition ID 29914BR

Job Title Principal Regulatory Affairs Specialist

Group MedSurg and Neurotech

Division Medical

Business Function Clinical Affairs

Country United States

State/Province WA

City Redmond

Employment Category Full Time

Percent Travel Required Up to 10%

Shift 1st

About Stryker

Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. 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 employer – M/F/Veteran/Disability.

Job Description / Information

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. Specialists whose motivation to be the best spurs them through distractions and continuous action.

Detail-oriented achievers. Focused professionals who are known for their strong analytical skills.

Game changers. Persistent associates who will stop at nothing to live out Stryker’s mission to make healthcare better.

What you will do

At Stryker, you are key to introducing our transformational medical technology solutions to the world. As a Principal Regulatory Affairs Specialist, you will address and negotiate regulatory requirements on everything from clinical research trials to global market releases.

In this role, you will develop and implement strategies that allow our innovative medical products to gain worldwide governmental approvals. Starting off in trial phases, you’ll collaborate with product development teams and clinical research partners to secure approvals for clinical investigations. When products are ready to be released to the market, you’ll prepare global regulatory submissions and negotiate their approval. Additional responsibilities include reviewing device labeling and advertising materials, reviewing and signing off on manufacturing changes, and providing regulatory input on quality assessments. 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.

Minimum Qualifications

What you need

Bachelor’s degree in Engineering, Biological Sciences or Allied Health Care. Equivalent combination of education and experience is acceptable.

• 8+ years of applicable Regulatory/Clinical experience

• Experience with MS Word, PowerPoint, MS Project, Adobe Acrobat, Excel, database, graphics presentation applications, document processing/publishing tools

• Preferred experience in Class I and Class II Medical Device Software products and device interoperability

• Thorough understanding of the following preferred:

• FDA medical device regulations, guidance, and import/exports requirements, labeling and promotional requirements

• Medical device quality systems

• Product development process

What We Offer

• A winning team driven to achieve our mission and deliver remarkable results

• Coworkers committed to achieving more and winning the right way

• 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 medical 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 your marketing and product management skills 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 employer – M/F/Veteran/Disability.

​​

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 employer – M/F/Veteran/Disability