Senior Regulatory Affairs Specialist- Trauma and Extremities (Remote)

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Posted 9 days ago United States Salary undisclosed
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Job Description

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 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: are currently seeking a Senior Regulatory Affairs Specialist to join our Trauma and Extremities EU MDR transition team to be based in Memphis, Tennessee or remotely anywhere within the United States.WHO WE WANT: • 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. • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.What you will do As a Senior Regulatory Specialist (EU MDR), you will be working on a team dedicated to the successful execution of Stryker's EU MDR transition program. This includes participating on cross-functional teams, authoring technical documentation and regulatory submissions, interacting with notified bodies, and managing changes as they relate to the EU MDR. Notable responsibilities include: Works collaboratively with cross-functional EU MDR teams to assist in compiling strong supporting documentation for the EU MDR transition of Stryker Trauma and Extremity devices. Authors, reviews and submits as necessary EU MDR Technical Documentation and General Safety and Performance Requirements in line with specified timelines. Contributes to developing and maintaining positive relationships with Notified Bodies through oral and written communications regarding pre-submissions strategies/ regulatory pathway development, submissions and follow-up on submissions under review to ensure timely approval. Reviews labeling to ensure applicable requirements are met Monitors impact of changing regulations and standards on product and submission strategies. Creates and/or edit regulatory SOPs as needed. Performs based on established targets, KPIs and objectives WHAT YOU NEED: A Bachelor's Degree (B.S or B.A) in Engineering, Science or equivalent focus required. 3+ years of experience in an FDA regulated industry required; preferably with medical devices. Thorough understanding of EU MDR requirements. General understanding of product development process and design control. Previous experience with Class II/III medical devices preferred. Previous experience drafting regulatory submissions to Notified Bodies preferred. Experience interacting with regulatory agencies preferred. Ability to comply with constantly changing regulatory procedures and prioritize work effectively. 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 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