Senior Regulatory Affairs Specialist- Trauma and Extremities (Remote)

Work Flexibility: Remote or Hybrid or OnsiteWe 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 metMonitors 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 objectivesWHAT 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.Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.