Senior Regulatory Affairs Specialist- continuous improvement & process design (Remote)

COVID-19 vaccination requirements

Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.

Why join Stryker?

We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Why regulatory affairs/quality assurance at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Stryker’s Neurovascular Division is seeking a Senior Regulatory Affairs Specialist to focus on continuous improvements and process design for the

regulatory affairs team. This role will be remote and can sit anywhere in the United States.

WHO WE WANT:

• Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

WHAT YOU NEED:

As the Senior Regulatory Affairs Specialist, you will plan, perform, and implement process improvement initiatives (such as Lean or Six Sigma) supporting the Regulatory Affairs facilitating cross-functional teams work to achieve continuous improvement objectives.

These actions include:

• Plans, performs, and implements process improvement initiatives (such as Lean or Six Sigma).

• Diagrams and evaluates existing processes and optimize or redesign process flows to achieve process improvements.

• Compile and track improvement project data and reports on status and develop metrics that provide data for process measurement, identifying indicators for future improvement opportunities and establish baseline metrics for “to” and “from” comparison.

• Provide support and guidance to team when needed.

• Develop and maintain process improvement policies and infrastructure.

• Work with function managers to identify opportunities for process improvements and long-term objectives and potential gains.

• Maintain/update resource allocation systems.

• Hold accountability to deliver on project tasks & meet project milestones.

• Perform responsibilities required by the Quality System and other duties as assigned or requested.

• Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).

WHAT YOU NEED:

• Bachelor’s degree required. Bachelor’s degree in engineering, science - preferred.

• 3+ years regulated work experience - required, preferably in a medical device and/or process improvement related work - preferred.

• Regulatory Affairs experience - preferred.

• Lean continuous improvement certification or equivalent work experience required, six sigma certification - preferred

• Competent with Microsoft Office (Visio, Outlook, Excel, Word, etc.).

• Ability to understand and explain detailed regulatory processes and/or issues.

• Ability to scope, plan, execute, and track projects with autonomy.

• Demonstrated ability to work effectively with cross functional resources.

• Excellent analytical and writing skills.

Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. In February 2019, Stryker Corporation (NYSE:SYK) announced that for the ninth consecutive year has been named as one of the FORTUNE 100 Best Companies to Work For ranking 11 out of 100. If you join our organization; will be working to “Make Stroke History”. Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg.

This job may be performed remotely from anywhere in the United States, except that this job may not be filled or performed in Colorado.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com