Ashlan Ziegelmeier
Andover
Summary
Customer-focused regulatory affairs professional with extensive experience supporting product lifecycle activities in highly regulated healthcare environments. Proven expertise in regulatory strategy, quality systems, and cross-functional collaboration to ensure compliance with U.S. and international requirements into practical, business-aligned guidance that supports product development, change management, and post-market compliance. Recognized for strong communication, analytical problem-solving, and the ability to influence stakeholders while maintaining a rigorous focus on patient safety, quality, and regulatory excellence.
Overview
15
15
years of professional experience
Work History
Business Application Consultant
Syntegon Packaging Technologies, LLC
10.2024 - 12.2025
- Conduct in-depth business process analysis to identify inefficiencies and provide tailored application solutions.
- Improve SAP workflows by implementing best practices that enhance user experience, data quality, and operational performance.
- Provide ongoing SAP user support, troubleshooting system issues, configuration errors, posting problems, and data inconsistencies.
- Resolve finance module issues during month-end close to ensure accurate reporting and system stability.
Technical Product Sales Specialist
Syntegon Pharma Technologies, LLC
12.2022 - 10.2024
- Led development, marketing, and strategy for single-use technology products aligned with business objectives.
- Serves as SME in biopharmaceutical manufacturing for single-use technology; provided technical guidance and customer solutions.
- Conducted market research and competitive analysis to identify opportunities and optimize product positioning.
Product Analyst II
Boston Scientific
08.2018 - 11.2022
- Manage complaint files for the Prostate Health Division in compliance with FDA and global regulatory requirements.
- Prepared and submitted FDA and Worldwide Vigilance reports using the Global Complaint Management System (GCMS).
- Led and completed complaint handling integration projects across multiple product lines.
- Trained teams on new device integrations and complaint handling processes.
- Assisted management in retrieving documentation and supporting regulatory audits.
Product Performance Analyst
Volt Technologies (On site Abbott)
02.2017 - 08.2018
- Manage complaint files within the Cardiac Rhythm Management Department.
- Prepared and submitted FDA and European Vigilance reports using the Customer Feedback & Resolution (CFR) System.
- Assisted file managers and cross-functional departments with complaint closures and investigations.
- Supported management on special projects related to product performance and regulatory compliance.
Quality Management System Analyst Supervisor
Pace Analytical (On Site 3M)
07.2016 - 02.2017
- Supervised Quality Management System Analysts supporting multiple departments at 3M within the healthcare sector.
- Evaluated team performance and communicated monthly metrics to client supervisors.
- Delivered monthly safety meetings and training presentations to employees.
- Provided system user training for various department stakeholders.
Quality Management System Analyst
Pace Analytical (On Site 3M)
01.2016 - 07.2016
- Manage complaints and submitted workflows to Quality Engineers, Medical Complaint Investigators, and Regulatory Affairs teams using Lotus Notes.
- Evaluated product credit requests and analyzed complaint samples.
- Consistently exceeded daily, weekly, and monthly performance goals.
- Supported additional 3M Healthcare divisions as needed, maintaining strong product knowledge.
Accounting Associate
Hays Companies
05.2011 - 12.2015
- Entered accounting transactions accurately into AMS360 and The Agency Manager (TAM).
- Processed journal entries, ensured proper documentation, and maintained financial records.
- Reviewed and approved employee expense reports.
- Communicated with auditors and account managers to resolve accounting discrepancies.
Education
Master of Science - Medical Technology Quality
St. Cloud State University
St. Cloud08.2020
Bachelor of Science - Biology & Chemistry
Augsburg University
Minneapolis05.2015
Skills
- Data analysis and product knowledge
- Customer relationship management
- Team collaboration and effective communication
- Quality assurance and performance optimization
- Expert problem solving and client rapport
- User training and regulatory compliance
- Public speaking
Awards
- Dale Carnegie Certificate - High Impact Presentations
- Silver Level CAPA Award
Timeline
Business Application Consultant
Syntegon Packaging Technologies, LLC
10.2024 - 12.2025
Technical Product Sales Specialist
Syntegon Pharma Technologies, LLC
12.2022 - 10.2024
Product Analyst II
Boston Scientific
08.2018 - 11.2022
Product Performance Analyst
Volt Technologies (On site Abbott)
02.2017 - 08.2018
Quality Management System Analyst Supervisor
Pace Analytical (On Site 3M)
07.2016 - 02.2017
Quality Management System Analyst
Pace Analytical (On Site 3M)
01.2016 - 07.2016
Accounting Associate
Hays Companies
05.2011 - 12.2015
Bachelor of Science - Biology & Chemistry
Augsburg University
Master of Science - Medical Technology Quality
St. Cloud State University