Arsalan Rizvi Email & Phone Number

- Managed team of eight compliance specialists responsible for Product Hold Order (PHO) execution across Medtronic- Ensured compliance of the PHO process and procedures with US and global regulations, international standards, and industry best practices- Led key strategic initiatives to standardize enterprise and global processes, reduce inventory on hold, and mitigate compliance risks in alignment with CQS annual strategic plans- Reduced PHO volume and aging across enterprise through influence and engagement with global cross-functional stakeholders within quality, supply chain, operations, and distribution - Drove visibility and accountability of key performance indicators to senior leadership - Coached and mentored team members to serve as front room SMEs for multiple FDA inspections, notified body audits, and internal audits

- Led cross-functional teams across quality, regulatory, medical safety, sales, marketing, regional partners, and other key stakeholders to craft and execute Field Corrective Action (FCA) Plans - Amplified input and feedback from cross-functional stakeholders to ensure senior leadership awareness and alignment- Interfaced with the US FDA for 806 reports, regulatory requests for information, and additional correspondence for Neuroscience portfolio FCAs- Onboarded and mentored new team members on US and global recall regulations as well as FCA program management best practices- Served as front room FCA process SME for multiple FDA inspections, notified body audits, and internal audits

Greater Denver Area

- Led cross-functional teams across quality, regulatory, medical safety, sales, marketing, regional partners, and other key stakeholders to craft and execute FCA Plans - Managed team of six contractors, including four offshore contractors- Interfaced with US FDA and EU competent authorities for initial recall submission reports and subsequent correspondence- Led the MDR Risk Management & Post Market Surveillance workstream on Neurosurgery EU MDR Core Team, responsible for EU MDR implementation across five Medtronic Neurosurgery sites- Developed and managed EU MDR Risk/PMS implementation projects for Neurosurgery, including long-term strategy development, budget planning, and project management - Oversaw cross-site team across five sites to plan, execute, monitor, and report on EU MDR Risk/PMS implementation plans

Greater Denver Area

- Helped maintain overall state of compliance of MNav quality system with all applicable regulatory requirements, quality standards, corporate policies, and site procedures- Led MDSAP readiness project each year in collaboration with process owners across quality, regulatory, operations, engineering, and services in anticipation of annual recertification audits- Managed team of process owners across multiple functional groups to revise local processes and update procedures as part of ISO 13485:2016 implementation project to bring MNav quality system in compliance with revised ISO requirements- Collaborated with cross-functional teams to revise local processes to ensure harmonization with ongoing revisions to Enterprise policies and procedures- Proactively identified and rectified compliance gaps as part of Enterprise IKM process as well as post-audit OFI process in collaboration with cross-functional teams - Participated in all internal and external audit preparation, execution, and follow-up activities- Served as Quality Systems representative on Louisville EU MDR Project- Assisted with CAPA and PNC investigation and effectiveness activities

Greater Denver Area

- Oversaw complaint files through all stages of investigation process to ensure compliance with regulatory requirements as well as corporate and site procedures- Evaluated complaints for reportability to FDA based on CFR 803 requirements - Submitted MDR and Adverse Event reports to FDA via eMDR tool- Liaised with field representatives, quality engineers, and tech services to ensure complaints are thoroughly investigated - Managed and led projects for compliance and process improvement initiatives- Participated in cross-functional teams for root cause analysis on CAPA projects - Supported regulatory audits (ISO, MDSAP) to ensure overall compliance of quality system- Tracked department performance on corporate metrics and escalate as appropriate - Participated as guest auditor during internal audits of other sites within Medtronic Restorative Therapies Group (RTG)

Greater Denver Area

- Maintained the quality system in compliance with 21 CFR 211, 21 CFR 820, ISO 13485, CMDCAS, and MDD- Reviewed and performed final batch release of finished pharmaceutical products- Evaluated, approved, and monitored quality status of suppliers - Served as management representative with FDA, ISO, and third-party auditors- Conducted internal quality system audits as well as external supplier audits- Reviewed and approved standard operating procedures, drug and device master records, and specifications- Oversaw and coordinated comprehensive investigations of quality events such as complaints, deviations, and CAPAs- Provided orientation in GMP and quality principles to new employees - Administered document control, approval, and distribution- Liaised with senior management to establish and achieve long-term quality benchmarks

Greater Denver Area

- Performed complaint and nonconformance investigations- Administered document control and management- Participated in supplier audits and evaluations- Provided GMP orientation and training to new employees

Greater Denver Area

- Helped students and faculty members troubleshoot operating system crashes, software malfunctions, networking and connectivity problems, hardware defects, etc. - Performed remote troubleshooting, offered over-the-phone customer service, and provided walk-in services

- Developed and validated novel separation methods to determine the presence of emerging classes of contaminants- Performed solid phase extraction for various pharmaceutical and biochemical samples - Applied chromatographic separations for food, drug, and environmental analysis along with advanced detection techniques, including tandem mass spectrometry- Developed standard operating procedures for HPLC, UV-VIS, and MS equipment- Maintained and repaired various analytical laboratory instruments, equipment, and solutions

Bachelor'S Degree, Chemistry

High School