Work Flexibility: Hybrid Stryker is one of the world’s leading medical technology companies and, together with its 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 130 million patients annually. More information is available at www.stryker.com We are currently seeking a Staff Regulatory Affairs Specialist to join our Medical Division. This is a hybrid role based in Cary, IL. 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. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices. Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams. What you will do As the Staff Regulatory Affairs Specialist, you will provide information used to evaluate proposed products for regulatory classification and jurisdiction. You will research requirements (local, national, international), applicable guidance and standards and options of regulatory submissions, approval pathways, and compliance activities. Prepare and author FDA-required Annual Reports for New Drug Applications. Assess the appropriate regulatory reporting mechanism using FDA regulations, guidance documents, and in-house policies upon review of Change Control Documentation. Assess and author amendments and supplements to product marketing applications. Provide regulatory guidance to other departments for planned changes. Provide a critical detailed review of technical documentation prior to FDA submission. Compile information and data about regulatory and project requirements including assessing needs; identifying the project’s critical factors; presenting decision-makers with options; and applying strategies. Communicate with regulatory agencies regarding pre-submission strategies/regulatory pathway development, submissions, and follow-up on submissions in review. Serve as partner to marketing, engineering, clinical and quality on project and product development teams. Improve awareness, visibility, and communication on regulatory requirements to support company goals and priorities. What you need A minimum of a Bachelor’s Degree (B.S. or B.A.) in Science, Engineering or equivalent focus required. A minimum of 5 years of experience in an FDA or highly regulated industry required; preferably with pharmaceuticals and medical devices. A minimum of 2-3 years in a Regulatory Affairs role required. Previous experience with Class II/III medical devices preferred. Previous experience drafting 510(k)s preferred. RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred. Experience authoring regulatory submissions for product approval preferred. Experience interacting with regulatory agencies preferred. 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. 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. Stryker is one of the world’s leading medical technology companies and, together with its 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 World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.