As a Product Regulatory Engineer, you will lead the development, implementation, and maintenance of a global regulatory compliance strategy across diverse product lines.
You'll work cross-functionally with R implement mitigation plans.
Manage end-to-end product approval and certification processes for all global markets.
Prepare and submit technical files, test reports, and declarations of conformity.
Coordinate product testing with internal and external laboratories.
Maintain all certifications, licences, and declarations to ensure continuing compliance.
Lead audits, inspections, assessments, and corrective actions.
Respond to regulatory inquiries, negotiate timelines, and resolve compliance issues.
Collaborate with Quality to embed regulatory requirements into the QMS.
Deliver training on regulatory expectations and best practices.
Ensure labelling, manuals, and marketing materials meet regulatory standards.
Track and assess design or component changes to ensure ongoing compliance.
Coordinate recall or corrective action activities where required.
Essential Qualifications