Staff Specialist, Regulatory Affairs

Staff Regulatory Affairs Specialist – Overview Work Flexibility: Remote, Hybrid, or Onsite. Location: Mahwah, NJ. Stryker is hiring a Staff Regulatory Affairs Specialist to support new product development for our Joint Replacement implant and instrument portfolio across U.S. and international markets. Responsibilities Assess regulatory intelligence and update local, regional, and global regulatory strategies based on evolving requirements. Evaluate the regulatory environment and provide guidance across product lifecycle phases including development, manufacturing, and commercialization. Determine product classification, submission requirements, and approval pathways across domestic and international markets. Prepare and submit regulatory filings in accordance with applicable global regulations and timelines. Identify regulatory risks and obstacles, propose mitigation strategies, and recommend refinements based on regulatory outcomes. Provide regulatory guidance on quality, preclinical, and clinical documentation to ensure submission readiness and compliance. Communicate with regulatory authorities to support submissions, monitor review progress, and respond to agency requests. Develop or update regulatory procedures and train cross-functional stakeholders to maintain compliance across the organization. Qualifications Bachelor’s degree required; preferred in Engineering, Science, or a related field. Minimum 4 years of experience in regulatory affairs within a regulated industry. Experience within the medical device industry. Preferred: Master’s degree in Regulatory Science or a related discipline. Preferred: Regulatory Affairs Certification (RAC). Knowledge of 510(k) and/or CE marking pathways. Experience preparing and submitting regulatory filings (e.g., FDA, EU, or international submissions). Experience supporting product lifecycle regulatory activities (development through post‑market). EEO Statement 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. #J-18808-Ljbffr Stryker Corporation