Why RA/QA 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 RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

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

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

Our benefits include bonuses; healthcare; insurance benefits; retirement programs; stock based 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.

We are currently seeking a Senior International Regulatory Affairs Specialist to join our Stryker Medical Division to be based remotely anywhere within the US.

Who we want

• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

• 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.

• Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do

As the Senior International Regulatory Affairs Specialist, you will provide solutions adapted to the global market. With a diverse portfolio of products that includes pharmaceuticals, medical devices, and cosmetics, this role will play a critical part in our continued global growth plan. In this role, you will:

• Evaluate, prepare, and submit global registration applications with a focus on timeliness and follow-through to ensure a positive outcome.

• Serve as a resource to broader RA team as well as working closely with marketing, sales, engineering, product development and quality.

• Manage projects with an emphasis on strong communication and coordination.

• Provide strategic guidance on global regulatory submissions.

What you need

• Bachelors Degree in Engineering, Science or related required

• Masters Degree or RAC preferred

• Minimum of 3 years' experience in an FDA or highly regulated industry required; preferably with medical devices

• Minimum of 1-2 years in a Medical Device Regulatory Affairs role required; international regulations experience strongly preferred

$73,100 - $152,400 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based location. Individual pay is based on skills, experience, and other relevant factors.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com