Principal Regulatory Affairs Specialist

Work Flexibility: Hybrid**Preferred*** At**least 5**years in medical industry, Regulatory Affairs or Engineering.* **RAC certification** or **Advanced Degree** (Master’s in Regulatory Affairs).* Previous**drafting regulatory submissions.**Posted: January 06, 2026Travel 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.**What you will do**As the Principal Regulatory Affairs Specialist, you will develop and implement environmental compliance strategies to meet global, federal, and local regulations, including RoHS, REACH, WEEE, Proposition 65, EU MDD, and EU MDR. You will influence design and manufacturing processes for new product development and sustaining projects, resolve escalations, and manage day-to-day compliance issues such as tender requests, customer inquiries, and reporting.* Develop and implement global product environmental compliance strategies to meet international, federal, state, and local regulations (e.g., RoHS, REACH, WEEE, Proposition 65, EU-MDR).* Own and manage the Environmental Compliance Process for Acute Care and Emergency Care business units.* Lead cross-functional teams to ensure compliance requirements are integrated into new product development and sustaining projects.* Influence design and manufacturing processes to meet environmental compliance standards and drive process improvements.* Engage and guide suppliers in developing environmentally compliant processes and controls for new and existing products.* Oversee compliance technology systems for tracking, reporting, and maintaining environmental stewardship programs.* Monitor and assess emerging regulations and trends, driving necessary changes into product development and sustaining plans.* Prepare and submit regulatory reports (e.g., WEEE, Battery, Packaging) and respond to audits, inspections, and customer questionnaires.* Train, communicate, and document compliance programs across global teams to ensure sustainable and effective processes.* Present compliance risks during project reviews and provide objective evidence for design verification and validation deliverables.**What you need*** Bachelor’s**degree** in Engineering, Science, or a related field (B.S. or B.A.).* Minimum**9 years of experience** in a regulated industry.* Thorough knowledge of **FDA and international medical device regulations.**We are seeking a **Principal Regulatory Affairs Specialist** to join our **Medical Division**. This **Hybrid** role will be based in **Portage, MI**, offering the opportunity to combine on-site collaboration and remote flexibility. experience - Experience **interacting with regulatory agencies.**- Strong ability to **analyze complex compliance challenges** and provide solutions. #J-18808-Ljbffr