Staff Regulatory Affairs Specialist ()

Company: Stryker
Location: Charleston
Posted on: June 10, 2021

Job Description:

About StrykerStryker is one of the worlds 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 Worlds Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting We are currently seeking a Staff Regulatory Affairs Specialist to join our Biologics Team in the Trauma & Extremities Division to be based in Memphis, TN or anywhere within 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 Staff Regulatory Affairs Specialist, you will support Strykers 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 Bachelors Degree (B.S or B.A) in Engineering, Science or equivalent focus is required. A minimum of 5 years of experience in an FDA regulated industry required; preferably with medical devices. A minimum of 2 years of Medical Device Regulatory Affairs experience required. Advanced Degree preferred. Previous experience with 510ks, PMAs, BLAs, combination products and/or human tissue products preferred. General understanding of product development process and design control. Thorough understanding of FDA and international medical device regulations. Previous experience drafting regulatory submissions required. Experience interacting with regulatory agencies required. 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. #LI-Remote Know someone at Stryker?Be sure to have them submit you as a referral prior to applying for this position.

Keywords: Stryker, Charleston , Staff Regulatory Affairs Specialist (), Other , Charleston, West Virginia