Regulatory Affairs Specialist- Lower Extremities/Biologics

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 the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

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. 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 team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Stryker is seeking to hire a Regulatory Affairs Specialist to support the Trauma and Extremities Biologics portfolio. This position is hybrid (on-site & work from home) based in either Memphis, TN, or Franklin, TN.

WHO WE WANT:

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

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

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

• Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

WHAT YOU WILL DO:

As the Regulatory Affairs Specialist, you will support Stryker’s Biologics portfolio. You will work with minimal supervision to bring medical devices to market and ensure ongoing compliance. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluate proposed device changes. You will assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.

• Prepare pre-submission and submission packages for regulatory agencies

• Research requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activities

• Assist in the development of regulatory procedures and SOPs

• Collect and organize information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulations

• Organize materials from preclinical and clinical studies for review

• Assist in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings

WHAT YOU NEED:

• Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.

• 0+ years relevant work experience required.

• 1+ years Regulatory Affairs experience preferred.

• 1+ years Medical Device experience preferred.

Our benefits

Our total rewards offering varies by country but often includes 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.

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/