Work Flexibility: Hybrid or Onsite WHO WE WANT 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 Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to be ready for what’s next 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 WHAT YOU WILL DO In this Regulatory Affairs Specialist role at Stryker, you will support our comprehensive Foot and Ankle portfolio primarily for the US and EU markets. You will learn to be a key regulatory partner that will work directly with global cross functional teams on new product initiatives during new product development, changes to product, advising the business towards regulatory compliant launches at all stages of design. You will assist in preparing regulatory submissions (PMA, 510(k), EU MDR technical documents, etc.) Obtain information used to evaluate proposed products for regulatory classification and jurisdiction Research requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activities Collect and organize information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulations Organize materials from preclinical and clinical studies for review and assists in the review process Compile and organize materials for pre-submission reports and communications Assist in the preparation of dossiers and pre-submission and submission packages for regulatory agencies WHAT YOU NEED BS in Engineering, Science, or related required 0 yrs experience RACS certification preferred 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.