Ryan Zigler Email & Phone Number

Ellettsville, IN, US

• Responsible for the integration of new complaint processing teams into global corporate structure, to centralize four post-market surveillance complaint handling sites and procedures into one workstream. Participated.
• Successfully drafted and routed intercompany quality agreements and interim controls for signatures within a 4-week period.
• Developed, monitored and presented weekly KPI results to executives and global project managers for successful site responsibility transition activities.
• Presented evidence to global project leaders to facilitate project progression, signoffs and buy-in.
• Developed regulatory Reporting Guidance Document for four manufacturing sites in alignment with corporate QMS requirements.
• Managed international team with two workflows consisting of two team leads and their respective complaint handlers, approvers, engineers and complaint initiators.

Warsaw, Indiana, United States

• (Regulation (EU) 2017/745 Article 87). Responsible for product segment’s monthly Key Performance Indicator tracking and reporting to department lead. Accountable for weekly team metric tracking and communicating.
• Developed new system for tracking product segment’s monthly metrics.
• Designed new metric reports to effectively communicate weekly feedback to the team.
• Supported multiple CAPA containment review and protocol validation efforts.
• Developed complaint file auditing sample plan and conducted subsequent monthly audits.
• Served as team SME for complaint handling, investigations, and final complaint approval.

Warsaw, Indiana, United States

• Evaluated adverse event and malfunction reports to determine documentation and reportability requirements in accordance with 21 CFR Part 803 Medical Device Reporting and 21 CFR Part 820 Quality System Regulation.
• Mentored and trained new team members to complete tasks in compliance with corporate procedures.
• Engaged in cross-functional regulatory Reporting Guidance Document updates to ensure proper and consistent regulatory reporting.
• Served as the product segment’s final complaint approver; ensuring each complaint contained proper documentation and associated regulatory reports.
• Assessed team’s weekly workload and completed weekly reports to track progress.
• Developed and presented quarterly complaint process refresher training for the complaint handling department.

Warsaw, Indiana, United States

• Evaluated adverse event and malfunction reports to determine documentation and reportability requirements in accordance with 21 CFR Part 803 Medical Device Reporting and 21 CFR Part 820 Quality System Regulation.
• Analyzed data and information received regarding product experiences and adverse events.
• Assessed adverse event reportability to applicable regulatory bodies.
• Submitted adverse event reports to FDA.
• Collaborated cross-functionally to perform gap analyses between department processes and FDA regulations.