New

Global Regulatory Services Quality Compliance Project Lead - GRS-QC Project Lead

Equiliem
United States, Minnesota, St. Paul
Apr 04, 2025
Global Regulatory Services Quality Compliance Project Lead - GRS-QC Project Lead Job Description: The Global Regulatory Services Quality Compliance Project Lead is responsible for supporting the RA procedure harmonization and related maintenance activities post harmonization. Regulatory processes have been harmonized across 6 Client medical device business units: Vascular, Neuromodulation, Structural Heart, Electrophysiology, Cardiac Rhythm Management, Heart Failure. This position will require strong project management skills to drive meetings and business unit process alignment. This person will report to the Global Regulatory Operations - Quality & Compliance Manager. They will work with the cross-business unit RA harmonization teams to update procedures, obtain cross functional review, route documents through the change order process and revise training audiences as necessary. This person will get experience structuring procedures, work instructions and guidance documents within the Client Quality Systems. Responsible for: Lead procedural updates and emerging regulation implementation working with cross BU/ cross functional teams Drive change order activities, supplemental training materials and related implementation activities Review and follow document quality system structure Develop, redline, and compile feedback on GRS owned procedure, work instructions, forms, and templates Lead team meetings and document meeting minutes Develop and implement process related training material Facilitate procedure implementation RA QA experience desired: Regulatory Change Assessment International Product Registration support Procedural Writing Ad and Promotional Material - Regulatory Review Project management skills - organize and host meetings Quality System maintenance activities Documenting Justification for change from Regulatory perspective Qualifications/Skills desired Bachelor's Degree 5+ years experience in a regulated industry Familiarity with Regulatory Affairs departmental responsibilities and processes Independent Problem Solving Technical writing skills Strong communication skills (written and verbal) Proven success managing multiple projects and priorities Attention to detail Proficient in Microsoft Word, Visio, and PowerPoint CAPA experience Windchill experience