Job Description

Are you interested in working for a global company where you can work across functions and on awide-varietyof projects As a member of Stryker\'s RA/QA team, that is exactly what you will do! Here, we provide our RA/QA 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/Quality Assurance team:https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team 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. Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions. Delivers results. A driven player who sets high goals for personal achievement and organizational success. He/she measures success against the best internal and external benchmarks What you will do: Support management of labeling approval and release, coordinating labeling through project development cycles Possess and apply knowledge and understanding of the global regulatory labeling requirement. Creates, reviews, and releases text that meets all medical, legal, and regulatory requirements for labeling medical products. Review external standards for compliance assessment. Review labeling and marketing literature for compliance with regulatory requirements. Process and implement IFU related change requests, including management of approval processes and implementation. Assist in corporate oversight of labeling standards, requirements, data, technical solutions, business process, infrastructure, licenses, etc Subject Matter Expert within Stryker on the requirements of global labeling, electronic IFUs, content management systems, and translations Participate in managing the IFU/eifu system, including review of requirements and existing IFUs. Utilize and comply with Stryker\'s Quality Management System including proactively verifying if requirements are met and managing changes within the Quality System Drive coordination with different departments to ensure the resulting IFU/Collateral Material is compliant, and effective Review & approval co-ordination of non-labelling jobs. Contribute to the weekly released report & maintenance of artwork archives Publication and/or uploading of approved documents on global portals Translation coordination of technical documentations Supporting labelling & collateral supporting system for periodic updates & reports Print current labels for Regulatory Authority registration requests & Support with printing current/updated labels during mass changes Language Independent document formatting Represent Global Labeling as Local Project Coordinator on major projects Process and implement IFU/IFP-related change requests, including management of approval processes and implementation. Assist as required with Production IFU/IFP issues and problems. Participate in managing the IFU/IFP system, including review of requirements and existing IFPs/IFPs Utilize and comply with Stryker\'s Quality Management System including proactively verifying if requirements are met and managing changes within the Quality System Create & manipulate logotypes, symbols and other graphics for inclusion on IFUs/IFPs. Subject Matter Expert within Stryker on the requirements of electronic IFUs/IFPs, content management systems, and translations. - executive sponsors to user level. Assist in corporate oversight of labeling standards, requirements, data, technical solutions, business process, infrastructure, licenses, etc. Drive coordination with different departments to ensure the resulting IFU/Collateral Material is compliant, and effective. Initiate and maintain effective collaboration between the Technical Publications team and engineering groups What you need: Educational background of bachelor\'s degree in Technical Writing or Technical Communications / Mechanical / Computer Science / Biomedical / English A minimum of 8 years of experience in an FDA regulated industry required. A minimum of 5 years of Regulatory Affairs experience required. Direct Medical Device Labeling experience 5years\' experience indesigning, writing, and publishing technical documentation (labelling/technical publication/collateral materials) Excellent verbal and written communications focused on scientific or technical communications Characterized by analytical and transdisciplinary reasoning, with a good attention to detail. About Stryker Stryker is one of the world\'s leading medical technology companies and, together with our customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually. More information is available at

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