Senior Regulatory Affairs Specialist (Remote) (R454826)
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.comWhy 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
We are currently seeking a Senior Regulatory Affairs Specialist to join our Biologics Team in the Trauma & Extremities Division to be based in Memphis, TN or remotely anywhere in the United States.
Who we want
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.
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 Senior 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.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions
Provide regulatory input and technical guidance for product development and planning throughout the product lifecycle
Assess the acceptability of quality, preclinical, and clinical documents for submissions to comply with applicable regulations
Evaluate proposed changes for regulatory submissions and propose strategies for changes that do not require submissions
Provide regulatory input and guidance for proposed product claims/labeling
Ensure that the clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
Communicate and interact with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
WHAT YOU NEED:
A Bachelor’s Degree (B.S or B.A) required; preferably in Engineering, Science or equivalent focus.
A minimum of 3 years of work experience required, preferably in an FDA or highly regulated industry.
A minimum of 2 year in Medical Device Regulatory Affairs or Engineering role required.
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
General understanding of product development process and design control preferred.
Previous experience with US Class II/III medical devices preferred.
Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
Ability to analyze and resolve non-routine regulatory issues using independent judgment.
Excellent analytical and writing skills.
Excellent interpersonal, written and oral communication skills.
Effective organizational skills.
Advanced PC skills with proficiency in Microsoft office Suite, including Excel.
This job may be performed remotely from anywhere in the United States, except that this job may not be filled or performed in Colorado.
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/