Ashley Reinhardt
San Diego,California
Summary
Diligent and spirited professional working as a Regulatory Operations Specialist with Medtronic Cardiac Rhythm Management unit. This experience fostered collaboration with other individuals in order to ensure compliance with cardiac device submissions to the FDA, with the overall goal of improving human welfare. Currently in search for work that will allow expansion on these skills to drive meaningful changes and yield impactful results.
Overview
6
6
years of professional experience
Work History
REGULATORY OPERATIONS SPECIALIST
Medtronic Inc.
11.2021 - Current
- Collaborates with partners throughout operating unit to prepare and publish various types of submissions to the FDA for Class III devices including: 510(k), 30-day, 180-day, Real-Time Reviews, Annual Reports, IDE, and Emergency Use submissions
- Increases work efficacy by creating and maintaining regulatory operations playbooks
- Files and records various documentation within regulatory management systems
- Manages Submission Services team mailbox to streamline communication between team members and management
- Tracks submission metrics received by FDA to be further evaluated by cardiac operating units.
OFFICE ASSISTANT
Wisconsin Medical Alumni Association
09.2018 - 08.2021
- Assisted in planning and organizing events in order to maintain network between alumni and current medical students
- Coordinated volunteering and shadowing opportunities for students of the school
- Monitored gifts and pledges to track financial contributions
- Drafted letters to recognize those who donated and encourage future acts of generosity
- Provided administrative support by updating files and records allowing for easy retrieval and access in electronic systems
- Managed social platforms to encourage participation in planned events and fundraisers.
RESEARCH ASSISTANT
UW Madison School of Human Ecology
05.2020 - 05.2021
- Worked with principal investigators to coordinate qualitative research into individual areas of impact for analysis
- Collaborated with leadership team to identify relevant questions and determine best methods of collection
- Conducted, researched and drafted memos and summaries on qualitative aspects of research
- Cleaned and coded transcripts taken from interviews with study participants.
Education
Bachelor of Science -
University of Wisconsin Madison
Madison, WI05.2021
Skills
- Proficient in Microsoft
- Proficient in Smartsheet
- Data Organization
- Team Communication
- Project Management and Support
- Attention to Detail
- Oral and Written Communication
- Critical Thinking
Timeline
REGULATORY OPERATIONS SPECIALIST
Medtronic Inc.
11.2021 - Current
RESEARCH ASSISTANT
UW Madison School of Human Ecology
05.2020 - 05.2021
OFFICE ASSISTANT
Wisconsin Medical Alumni Association
09.2018 - 08.2021
Bachelor of Science -
University of Wisconsin Madison