Principal Regulatory Affairs Specialist

We are seeking aPrincipal Regulatory Affairs Specialistto join ourMedical Division. This Hybrid role will be based inPortage, 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.

• Developand implement global product environmental compliance strategiest to meet international, federal, state, and local regulations (e.g., RoHS, REACH, WEEE, Proposition 65, EU-MDR).
• Ownand manage the Environmental Compliance Processfor Acute Care and Emergency Care business units.
• Leadcross-functional teamsto ensure compliance requirements are integrated into new product development and sustaining projects.
• Influencedesign and manufacturing processsto meet environmental compliance standards and drive process improvements.
• Engageand guide suppliers in developing environmentally compliant processes and controls for new and existing products.
• Overseecompliance technology systemsfor tracking, reporting, and maintaining environmental stewardship programs.
• Monitorand assess emerging regulations and trends, driving necessary changes into product development and sustaining plans.
• Prepareandsubmitregulatory 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.
• Presentcompliance risks during project reviewsand provide objective evidence for design verification and validation deliverables.

What you need

• Bachelor’sdegreein Engineering, Science, or a related field (B.S. or B.A.).
• Minimum9 years of experiencein a regulated industry.
• Thoroughknowledge of FDA and international medical device regulations.

Preferred

• Atleast 5years inmedical industry, Regulatory Affairs or Engineering.
• RAC certificationorAdvanced Degree(Master’s in Regulatory Affairs).
• Previousexperiencedrafting regulatory submissions.
• Experienceinteracting with regulatory agencies.
• Strong abilitytoanalyze complex compliance challengesand 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