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 youwill 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 strategiesto 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 processesto meet environmental compliance standards and drive process improvements.
• Engageand guide suppliersin developing environmentally compliant processes and controls for new and existing products.
• Overseecompliance technology systemsfor tracking reporting andmaintainingenvironmental 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 andvalidationdeliverables.

What you need

• Bachelorsdegreein Engineering Science or a related field (B.S. or B.A.).
• Minimum9 years of experiencein aregulated industry.
• Thoroughknowledge ofFDA and international medical device regulations.

Preferred

• Atleast 5years inmedical industryRegulatory Affairs or Engineering.
• RAC certificationorAdvanced Degree(Masters in Regulatory Affairs).
• Previousexperiencedrafting regulatory submissions.
• Experienceinteracting with regulatory agencies.
• Strong ability toanalyze complex compliance challengesand provide solutions.

Posted: January 06 2026