Work Flexibility: Remote Stryker Emergency Care is seeking to hire a Staff Regulatory Affairs Specialist to join our Medical Division in Redmond, WA. This role can be hybrid in Redmond, WA or remote anywhere in the US. As the Senior Regulatory Affairs Specialist, you will engage in technical and scientific regulatory activities to include project management, writing, coordination, and execution of regulatory documentation for Stryker’s AED and LIFEPAK 15 Monitor/Defibrillator product portfolio. LIFEPAK 15 monitor/defibrillator - proven clinical performance | Stryker (strykeremergencycare.com) These devices send data ahead to the receiving caregiving team to save time, ease handoffs, and improve patient outcomes. Emergency Care training videos and survivor stories | Stryker (strykeremergencycare.com) Stryker will offer you a competitive total rewards package, including competitive base salary, performance bonus, and benefits. We also offer other non-financial rewards, and engaging work environment and meaningful career advancement opportunity. Stryker Benefits 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. What you will do Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.) Assists in the development of regulatory strategy and updates strategy based upon regulatory changes Evaluates proposed products for regulatory classification and jurisdiction Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization Negotiates with regulatory authorities throughout the product lifecycle Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance Assists other departments in the development of SOPs to ensure regulatory compliance Provides regulatory input and technical guidance on global regulatory requirements to product development teams Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process Provides regulatory information and guidance for proposed product claims/labeling Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines Monitors the progress of the regulatory authority review process through appropriate communications with the agency Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees What you need: BS in Engineering, Science, or related degree; or MS in Regulatory Science 2 years’ experience in Medical Device Regulatory Affairs 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.