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Regulatory Affairs Project Leader

Spectraforce Technologies
United States, Minnesota, St. Paul
Mar 12, 2025
Job Title: Regulatory Affairs Project Leader Location: St. Paul, MN 55117 Duration: 6-Months (Possibility to extend and convert) Schedule: 8:00 am-5:00 PM Profile overview: The Global Regulatory Services (GRS) 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 medical device business units Support GRS owned CAPA activities related to RA procedural changes. These activities include managing GRS CAPA tracker, quality review for verification, lead CAPA correction and corrective action delegated activities and tasks. Duties: Responsible for: Lead procedural updates and emerging regulation implementation working with cross BU/ cross functional teams Review and approval of CAPAs with attention to detail, review of completeness, accuracy, effectivity and timeliness Drive change order activities, supplemental training materials and related implementation activities Execute CAPA Review board/Management Review forums 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 Identify continuous improvement and collaboration opportunities TOP 5 Desired qualifications and experience: 1. Procedural Writing 2. CAPA Expertise 3. Project management skills - organize and lead meetings for procedural development 4. 5+ years' experience in a regulated industry 5. Familiarity with Regulatory Affairs departmental responsibilities and processes Desired Qualifications: * Bachelor's Degree * Quality Systems experience desired * Must understand regulatory processes and be quality system oriented and have a background in both of these areas * Technical writing skills * Strong communication skills (written and verbal) * Proven success managing multiple projects and priorities * High Attention to detail * Proficient in Microsoft Word, Visio, and PowerPoint * Windchill experience a Plus but not Required