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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 Abbott medical device business units. 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 Senior Manager. 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. They will work with the cross-business unit RA compliance 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 Abbott Quality Systems

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Responsible fo

• r:Lead procedural updates and emerging regulation implementation working with cross BU/ cross functional tea
• msReview and approval of CAPAs with attention to detail, review of completeness, accuracy, effectivity and timeline
• ssDrive change order activities, supplemental training materials and related implementation activiti
• esExecute CAPA Review board/Management Review foru
• msReview and follow document quality system structu
• reDevelop, redline, and compile feedback on GRS owned procedure, work instructions, forms, and templat
• esLead team meetings and document meeting minut
• esDevelop and implement process related training materi
• alFacilitate procedure implementati
• onIdentify continuous improvement and collaboration opportuniti

es
TOP 5 Desired qualifications and experien

• ce:Procedural Writ
• ingCAPA Expert
• iseProject management skills – organize and lead meetings for procedural developm
• ent5+ years' experience in a regulated indus
• tryFamiliarity with Regulatory Affairs departmental responsibilities and proces

ses
Desired Qualificat

• ionsBachelor’s De
• greeQuality Systems experience des
• iredTechnical writing sk
• illsStrong communication skills (written and ver
• bal)Proven success managing multiple projects and priori
• tiesAttention to de
• tailProficient in Microsoft Word, Visio, and PowerP
• ointWindchill experience (not Required, but a P

lus)