Regulatory Affairs Project Leader

3 weeks ago


Saint Paul, United States Collins Consulting Full time

Looking for candidates local to the Maple Grove MN or St Paul MN area. This is an onsite position.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 Client 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.TOP 5 Desired Qualifications and Experience:Procedural WritingCAPA ExpertiseProject management skills – organize and lead meetings for procedural development5+ years’ experience in a regulated industryFamiliarity with Regulatory Affairs departmental responsibilities and processesDesired Qualifications:Bachelor’s DegreeQuality Systems experience desiredMust understand regulatory processes and be quality system oriented and have a background in both areasTechnical writing skillsStrong communication skills (written and verbal)Proven success managing multiple projects and prioritiesHigh Attention to detailProficient in Microsoft Word, Visio, and PowerPointWindchill experience a Plus but not Required #J-18808-Ljbffr



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