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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.

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 strategiesto meet international, federal, state, and local regulations (e.g., RoHS, REACH, WEEE, Proposition 65, EU-MDR).

+ Own and manage the Environmental Compliance Processfor Acute Care and Emergency Care business units.

+ Lead cross-functional teamsto ensure compliance requirements are integrated into new product development and sustaining projects.

+ Influence design and manufacturing processesto meet environmental compliance standards and drive process improvements.

+ Engage and guide suppliersin developing environmentally compliant processes and controls for new and existing products.

+ Oversee compliance technology systemsfor tracking, reporting, andmaintainingenvironmental stewardship programs.

+ Monitor and assess emerging regulations and trends, driving necessary changes into product development and sustaining plans.

+ Prepare andsubmitregulatory reports(e.g., WEEE, Battery, Packaging) and respond to audits, inspections, and customer questionnaires.

+ Train, communicate, and document compliance programsacross global teams to ensure sustainable and effective processes.

+ Present compliance risks during project reviewsand provide objective evidence for design verification andvalidationdeliverables.

What you need

+ Bachelor’s **degree** in Engineering, Science, or a related field (B.S. or B.A.).

+ Minimum **9 years of experience** in aregulated industry.

+ Thoroughknowledge of **FDA and international medical device regulations** **.**

Preferred

+ At **least 5** years in medical industry,Regulatory Affairs or Engineering.

+ **RAC certification** or **Advanced Degree** (Master’s in Regulatory Affairs).

+ Previousexperience **drafting regulatory submissions.**

+ Experience **interacting with regulatory agencies.**

+ Strong ability to **analyze complex compliance challenges** and provide solutions.

Posted: January 06, 2026

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.