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.

- 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.

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.

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.

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.

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.

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.

Bachelor'S Degree, Chemistry

High School