Job Description

Stryker Joint Replacement is seeking an entry-level Regulatory Affairs Specialist to be based hybrid two days per week in Mahwah, NJ. Why come to Stryker? Dozens of Reasons To Love Stryker 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. Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. 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. As the Regulatory Affairs Specialist for Market Continuity, you will work with cross-functional teams and global partners to help ensure continued compliance and marketability of Stryker’s medical devices within Joint Replacement Implants. You will participate in preparation and authoring of regulatory submissions for both the U.S. and global regions, assist in technical file reviews and updates, interact with regulatory agencies/notified bodies, and help evaluate the impact of evolving device regulations. This is a highly visible position with interaction and exposure to many partners across Stryker’s JRI division. What you will do Participate in product sustaining teams to ensure that Stryker continues to satisfy US, EU, and global regulatory requirements. Assist in preparation and authoring of FDA submission packages, EU design dossiers/technical files, and other product documentation for regulatory agencies. Partner with Stryker’s global affiliates to support international submissions and international regulatory notifications. Work with the Regulatory team, Stryker Global Technology Center, and cross-functional teams on base business including technical file updates, supporting audits, NC/CAPA, and maintaining regulatory procedures. Communicate information on regulatory requirements to other departments and business units. Identify information sources and collect, organize, and maintain files on local, regional, and global regulatory intelligence and other related information. Research requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activities. Assist in the review process of materials from clinical studies, post-market surveillance, NC/CAPA, marketing, technical publications, or other functional documents used to compile and update technical files. Track the status of applications under regulatory review and provide updates to the regulatory team. Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders. What you need BS in Engineering, Science, or related degree. 0-2 years of experience in an FDA regulated industry, preferably within medical devices. Time management skills, writing, coordination, and execution of basic regulatory items. #J-18808-Ljbffr

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