Allyson Nielsen
Hopkins,MN
Summary
Accomplished medical device reporting specialist skilled in regulatory compliance and data-driven process improvement. Demonstrated ability to lead continuous improvement projects, mentor teams, and maintain strong customer relationships while ensuring adherence to industry regulations.
Overview
1
1
Certification
12
12
years of professional experience
Work History
Medical Device Reporting/Vigilance Specialist
Medtronic
Mounds View, MN
07.2025 - Current
- Held the Asia Pacific (APAC) charter lead role, collaborating with regional compliance leaders and business unit functional leaders to understand and comply with regional regulations including Japan, South Korea, and India.
- Managed continuous improvement projects using DMIAC approach, focusing on complaint reduction, automation, and customer quality enhancements.
- Implemented process improvements to achieve key enterprise metrics in APAC region.
- Maintained professional and customer-focused communication with external partners to adhere to and enhance Medtronic mission.
- Analyzed and communicated data to senior leadership using PowerBI.
- Owned a cell operating system (COS) transformation sub-system, applying visual management improvements to the cell infrastructure.
- Mentored new hires on spinal cord stimulator product functionality, and complaint record processing.
Associate Medical Device Reporting/Vigilance Specialist
Medtronic
Mounds View, MN
03.2016 - 07.2025
- Monitored medical device surveillance program, managing intake, protocol development, evaluation, processing, and follow-up on adverse reports to ensure compliance with government regulations and minimize legal liability.
- Maintained and reported Medical Device Reports (MDRs) and Adverse Drug Experience (ADE) data for regulatory compliance.
- Ensured quality system compliance by assessing, evaluating, investigating, and documenting incoming Neuromodulation product complaints, contributing to regulatory adherence.
- Wrote and completed regulatory submissions in conjunction with US and OUS regulatory guidelines for class III medical devices within Neuromodulation division.
- Prepared documentation and reports for regulatory submissions, facilitating compliance and supporting successful approval processes.
- Developed and maintained documentation for compliance standards.
- Analyzed data to identify process improvements in operations.
- Managed training sessions for new employees on operational procedures.
- Participated in ongoing training and compliance activities.
Head Coach-Volunteer
Minnesota Special Hockey
Blaine, MN
11.2014 - 03.2021
- Taught fundamental hockey skills to children with disabilities, leading practices and games to enhance their abilities.
- Fostered positive, inclusive atmosphere that promoted athlete development and boosted confidence.
- Developed training programs for athletes with diverse abilities.
- Coordinated practice schedules and game strategies for the team.
- Mentored assistant coaches in implementing effective coaching techniques.
Biorepository Laboratory Technician
National Marrow Donor Program
New Brighton, MN
09.2014 - 03.2016
- Facilitated time-sensitive retrieval of biological specimen samples from storage for high-resolution typing.
- Received, processed, and stored tissue samples from potential donors and recipients for stem cell transplant.
- Coordinated shipment of high-priority samples with lab service team members to ensure timely delivery.
Education
Bachelor of Arts - Biology, Management minor
College of Saint Benedict
St. Joseph, MN05-2014
Skills
- Medical device reporting
- Regulatory compliance
- Adverse event monitoring
- Data analysis
- PowerBI proficiency
- Continuous improvement
- Process analysis
- Problem solving
- Analytical thinking
- Stakeholder engagement
- Team collaboration
- Mentoring new hires
Certification
- Lean Six Sigma yellow belt
- Medical Device Reporting
- Business Acumen 101
Timeline
Medical Device Reporting/Vigilance Specialist
Medtronic
07.2025 - Current
Associate Medical Device Reporting/Vigilance Specialist
Medtronic
03.2016 - 07.2025
Head Coach-Volunteer
Minnesota Special Hockey
11.2014 - 03.2021
Biorepository Laboratory Technician
National Marrow Donor Program
09.2014 - 03.2016
Bachelor of Arts - Biology, Management minor
College of Saint Benedict